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media/zoomImage_BBB0CE6B_DD40_7ADC_41E4_6D7FF3CB4CFF_en_0_0.png imlevel_C504CC99_C5D4_89AF_41D0_DEFE78188692.url = media/zoomImage_BBB0CE6B_DD40_7ADC_41E4_6D7FF3CB4CFF_en_0_1.png ### Popup Image ### Subtitle panorama_8B253560_BDE4_4D15_41C8_B539879E0F4B.subtitle = BSH Mammography Biopsy Room panorama_BF0BE690_F640_97F1_41EE_AFF43215FB59.subtitle = BSH Mammography Biopsy Room panorama_2D2BE7BB_18C9_730C_41B4_32F248788F19.subtitle = BSH Mammography Biopsy Room panorama_AD1EC5F6_C3B4_E28C_41E1_5EF1CF123D52.subtitle = BSH Bone Metabolic Health Room panorama_2D51F923_0649_E829_418D_A416986DDD75.subtitle = BSH Breast Surgery Room panorama_AF42C2C6_C38C_668C_41E4_9CDAD24172C9.subtitle = BSH Breast Surgery Room panorama_AB3F5FCF_C38C_1E9C_41D1_EB7CD093A82D.subtitle = BSH High Efficiency Biopsy Room panorama_AEC7CDA4_C394_E28C_41BC_F1EFF45400F0.subtitle = BSH High Efficiency Biopsy Room panorama_AAEE9934_C394_638D_41A0_88FDAD71395E.subtitle = BSH Mammography Biopsy Room panorama_A49B5A72_C39C_6184_41C9_090C44EA0A90.subtitle = BSH Pathology Lab panorama_A423D0AC_C39D_E29C_41D0_2D4CE7BA31C3.subtitle = BSH Reading Room panorama_A4258C25_C39C_E18C_41D5_BBCC73F54F70.subtitle = BSH Reception panorama_A4E4F80A_C39C_2184_41E5_8DB2CD076BCC.subtitle = BSH Reception panorama_A47294E9_C39D_E287_41E6_EF65DDFFEE62.subtitle = BSH Reception panorama_21F60951_CD42_8602_41DB_9D73A392ABB0.subtitle = BSH Screening & Diagnostic Room panorama_26BF7623_CD42_8A06_41E3_F7F689ACD133.subtitle = BSH Screening & Diagnostic Room panorama_C4EC3F9B_C45B_87A3_41C0_39B8EB12565E.subtitle = BSH Screening Room One panorama_A4EC3915_C394_238C_41DA_D2649E2EEFA7.subtitle = BSH Screening Room Two panorama_33B6D62D_18DF_9504_419A_1BE497C4F91C.subtitle = BSH Screening Room Two panorama_5E3D0766_7075_3F6B_41D6_6ECA2DC8A936.subtitle = BSH Screening Room Two panorama_2D59CCF2_0648_282B_4194_176FEC8BBC09.subtitle = BSH Ultrasound Biopsy Room panorama_A54CFCEB_C39C_2284_41D2_6CB31A4BB2B5.subtitle = BSH Ultrasound Biopsy Room panorama_ABE2899F_C394_62BC_41CC_17F73C4BBC3A.subtitle = Orthopaedic Surgery Room panorama_8C79525D_94C9_BAFC_41CC_A9540B0265D0.subtitle = Welcome ### Title video_6E1336A4_CDC7_8A02_41C0_EDCAE9AE9F3B.label = 06-CalibrationRev2 video_6EF74477_CDC5_8E0E_41E5_F573BDDF3CF8.label = 07-3DBEAM2HOLO video_6701ED77_188B_EE21_41AE_01043BB4C0E0.label = 1_MammographySystem_LateralArms_Render_01_ldt video_16BB12B1_51BF_C9F1_41C7_68698BDDD5DA.label = 1_MammographySystem_LateralArms_Render_01_ldt video_B8722057_F640_8B7F_41E8_DA8C80FCE37A.label = 1_MammographySystem_LateralArms_Render_02_ldt video_F4E16BFE_98C6_28CE_41AA_4C37A9657C54.label = 21HOL_GeniusAI_Animation_v4 video_7ED1EEF5_1CD2_8309_4184_82735DDBD3A4.label = 2_MammographySystem_ManualCompression_Render_01_ldt photo_72323E9C_61F6_0227_41D5_756B54FCB8AE.label = 3DQuorum® Imaging Technology-v2 photo_72323E9C_61F6_0227_41D5_756B54FCB8AE.label = 3DQuorum® Imaging Technology-v2 video_AD42FB08_BB5A_75A3_41D9_51FDAE8ACD3D.label = 3DQuroum Animation Video AVD-00518-EUR-EN_Rev_001-Video_3DQuorum video_2317903B_1CDD_9F79_41B5_038FA9A0C5CF.label = 3_MammographySystem_TubeAnimation_Render_01_ldt video_78C23ED2_1CD6_830B_4190_57BACDB11DE6.label = 4_MammographySystem_SmartPositioning_Render_01_ldt video_514CB7D2_5005_DD5C_41A4_22E929B6B772.label = 5_AWS_DynamicDisplay_Render_01_ldt video_FAF5FF16_5005_CEC4_41C9_AFBA7A1B4377.label = 5_AWS_DynamicDisplay_Render_01_ldt video_5105E515_5007_72C4_41D1_328AF5E15206.label = 8_3Dimensions_360_Render_01_ldt panorama_D4FA1A53_5004_F75C_41BA_559557B9219B.label = 9282_USVirtualHospital_ReadingRoom_180_001_ldt panorama_5E3D0766_7075_3F6B_41D6_6ECA2DC8A936.label = 9282_USVirtualHospital_ScreeningRoom_180-1_001_ldt panorama_33B6D62D_18DF_9504_419A_1BE497C4F91C.label = 9282_USVirtualHospital_ScreeningRoom_180-2_001_ldt panorama_8BF8B927_A2DE_ED0F_41D9_635133954A7E.label = 9583_US_VirtualHospital_Envision_180_C1_ldt panorama_85C79C64_A2DE_EB01_41B3_D4883E414951.label = 9583_US_VirtualHospital_Envision_180_C2_ldt video_8984ABB8_C984_60AD_41CA_C02EE27E32D2.label = ADS-00260-EUR-EN_001_01 video_DD6AEB12_CEBD_9DBE_41D3_A5551D1026BC.label = ADS-03025-EUR-EN_001_01 album_6ED9BF88_CB8C_E16D_41CA_BE0C636825A2_0.label = AP Spine Report video_89E27353_C984_21E3_41D5_C0FAD5396E79.label = AVD-00261-EUR-EN_001_01 video_7DA9467F_DDC1_8AB4_41D4_9BD5474D4B38.label = AVD-00262-EUR-EN_001_01 video_A36153C3_C98C_20E3_41E7_F59A330655F1.label = AVD-00286_Rev001_Affirm Prone with Brevera - short version video_0244E2AB_4BB3_17F1_41C1_58436673B71C.label = AVD-00286_Rev001_Affirm Prone with Brevera - short version video_F088934C_C99C_61E5_41DE_FA379D54C317.label = AVD-00432-EUR-EN_003_01_1 video_17AA9DAC_4BD1_0DF7_41B2_23EC68C0900A.label = AVD-00433 Rev 001- LOCalizer- Dr. Fine- Video video_F0FF2CF9_C984_E0AF_41E2_A78D5B945AA9.label = AVD-00433-EUR-EN_001_01_1 video_D329C156_D7B9_34B6_41DF_BB8BC85BFBF4.label = AVD-00439-EUR-EN video_E5905EDC_98FE_E8D2_41D0_7C56EDAFE74F.label = AVD-00455 Rev001_LOCalizer Explainer Update 2019 v4 video_2025C376_4BF1_1553_41CB_DDAAA288B634.label = AVD-00456 Rev001 BioZorb Explainer Video video_12648B0D_4BD3_16B1_41BF_ADCAAE01012B.label = AVD-00458 Rev001 LOCalizer- Dr. Berry Testimonial- Video video_F020528C_C984_2365_41A5_B28F91BA7C26.label = AVD-00458-EUR-EN_001_01_1 video_1CFA4BCB_4BD1_15B1_41C1_94F590F3CED0.label = AVD-00459 Rev001- LOCalizer- Dr. Fine Phyllodes Tumor Resection Video video_FEB03936_C984_21A5_41E2_389B94457A2B.label = AVD-00459-EUR-EN_001_01 video_27DC7F40_4BD1_0EAF_41B3_35A0887D7FE7.label = AVD-00470 Rev001 TruNode Explainer Update video_94E798CB_C984_E0E3_41C4_193D0C5C8FED.label = AVD-00470-EUR-EN_001_01_1 video_899F1A77_C983_E3A3_41C8_38703513C834.label = AVD-00536-EUR-EN_001_01 video_8802F957_C984_61E3_41D0_F1551AF02547.label = AVD-00753-EUR-EN_001_01 - 3Dimensions Video video_7A9AF90A_4AD7_12B3_41A1_EAA84E5E4C6A.label = AVD-01228 Simulated Procedure Video - Affirm Upright with Brevera - HD 1080p video_062CBCF7_4BB3_1351_41C2_D894A050F123.label = AVD-01353 Hologic Trident HD Demo Video video_8D83C7C4_C985_E0E5_41A6_327AC783A4A9.label = AVD-07693-EUR-EN_001_01 MIBS Brevera animated video V4 panorama_21F60951_CD42_8602_41DB_9D73A392ABB0.label = AWS video_81F1B608_A9DC_C5AB_41D8_009E0CBD41A7.label = Affirm® lateral arm upright biopsy accessory panorama_A4258C25_C39C_E18C_41D5_BBCC73F54F70.label = BSH Reception Left panorama_A4E4F80A_C39C_2184_41E5_8DB2CD076BCC.label = BSH Reception Right video_1E33D428_B9BB_E2B1_41C9_803171FC4E63.label = Basic overview of the 3Dimensions mammography system video_9F17273F_C984_61A3_41DF_27301BAA6DCD.label = Biozorb_Training_1 panorama_AD1EC5F6_C3B4_E28C_41E1_5EF1CF123D52.label = Bone Metabolic Health Room panorama_AF42C2C6_C38C_668C_41E4_9CDAD24172C9.label = Breast Surgery Room panorama_2D51F923_0649_E829_418D_A416986DDD75.label = Breast Surgery Room 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video_CE34590D_A4D1_F2DE_41B1_734FC63F5C8F.label = DA_03.5_MammographySystem_TubeAnimation_Render_01_hb video_13736C57_4C79_97BA_41D2_0D8C211C73CD.label = DA_03_MammographySystem_SmartPositioning_Render_01_hb video_D77A58BE_A450_533A_419C_2593799790DC.label = DA_04.5_MammographySystem_LateralArms_Render_02_hb video_F2BD73F3_4CB8_B07A_417D_028DD126A903.label = DA_04.5_MammographySystem_LateralArms_Render_02_hb video_D745DC19_4CAB_97B6_41C7_75E5DDCABF58.label = DA_04_MammographySystem_ManualCompression_Render_01_hb video_A9F431A8_4C59_9096_41C8_1F1E949D78A2.label = DA_05_Brevera_DualMonitors_Render_01_hb video_4C9EF459_4C69_97B6_41C0_10EA3DB4F7CD.label = DA_06_Akrus_AdjustableComponents_Render_01_hb video_4CA2FB70_4C59_9076_41CC_1BDE75327E95.label = DA_07_Akrus_AdjustableBracket_Render_01_hb video_4CC1FF9C_4DDB_90AE_41BC_DCDF40FBD4C3.label = DA_08_Akrus_TrendelenbergPositioning_Render_01_hb video_4CC60B24_4DD8_719E_41A8_3D4D95C36B72.label = DA_09_Akrus_BrakingSystem_Render_01_hb video_4CD54A43_4DF8_F39A_41C9_0D8537186A1B.label = DA_10_Akrus_ElectronicLife_Render_01_hb video_4CDFA8DB_4DE7_B0AA_4185_DB63276F9C52.label = DA_11_Mach30_Ergonomics_Render_01_hb video_F254F378_BDA5_C5F5_41E5_7605F8A13315.label = DA_11_Mach30_Ergonomics_Render_01_hb video_C2371DE6_E660_82DF_41E9_C052D38C7B09.label = DA_11_Mach30_Ergonomics_Render_02 video_D207A1A8_A451_B5C6_41D2_8E2BC915067D.label = DA_12_DXA_TableMovement_Render_01_hb video_DD6EBF93_A450_ADCA_41BE_DFBEE434D35F.label = DA_12_DXA_TableMovement_Render_01_hb video_742B1C5E_55EA_953A_41CD_5603E43255C6.label = DA_12_DXA_TableMovement_Render_01_hb video_70D3A74E_55DB_931A_41AD_0B96EF3D5E50.label = DA_13_DXA_RotatingCarm_Render_01_hb video_7F668EC4_55AA_950E_41C3_FEEC441AEFF1.label = DA_14_DXA_TrueFanBeam_Render_01_hb video_66E2413B_55AF_8F7A_41D2_D0FEE3E48387.label = DA_15_Affirm_TotalAccess_Render_01_hb video_1C390B09_5655_9306_41CD_77A16D9E827F.label = DA_16_Affirm_MaximumComfortPackage_Render_01_hb video_3009BD06_5675_970A_41D3_0CC118B6778E.label = DA_17_Affirm_TableLight_Render_01_hb video_CE4A1A85_5656_FD0E_418B_397D8619069F.label = DA_18_Affirm_TranslucentPanels_Render_01_hb video_EFFDD779_56AF_B306_41D0_9608BD393AA0.label = DA_19_Affirm_AngledBiopsy_Render_01_hb video_BE5B0458_56BD_9506_41B4_5AC4AB318A18.label = DA_20_Affirm_TubeHeadMotion_Render_01_hb video_5648A9AA_56D6_9F1A_41C6_1121FD4C26FE.label = DA_21_Affirm_AdjustableTrajectory_Render_01_hb video_5652D569_56FA_B706_41D0_94FDBD37234C.label = DA_22_Affirm_AdjustableHeight_Render_01_hb video_7AF1FEFB_56F8_9418_41C0_9F7884D2B01F.label = DA_23_MammographySystem_360-WhiteBackground_Render_01_hb video_78770DB3_56A8_B429_41D5_947EA2701061.label = DA_24_AcquisitionWorkstation_360-WhiteBackground_Render_01_hb panorama_E63C7E45_B50B_9CD7_41DD_29B1174EE96E.label = Envision Mammography Suite panorama_E5ECE20A_B508_A45D_41E3_2741A0E17A58.label = Envision Mammography Suite - With Wheelchair Accessibility 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Workflow Efficiency Calculator


For biopsy procedure volumes less than 100 per year,
please explore Room 3 – Mammography Biopsy Room.


For biopsy procedure volumes greater than 100 per year, please explore the
Affirm® Prone Biopsy System in Room 4 – High Efficiency Biopsy Room.
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john doe
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3DQuorum® Imaging Technology:
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Genius AI® Detection 2.0 Technology
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High Resolution Evolution:
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I-View® 2.0 Contrast Enhanced Mammography Software
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Quantra™ 2.2 Breast Density Assessment Software for 2D or 3D™
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Hologic Virtual Hospital
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Reference:
1. FDA submission: P080003/S001, 2013.
2. Skaane P, Bandos AI, Eben EB, et al. Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Radiology, 2014 Jun;271(3):655-63.
3. Zuley M, Guo B, Catullo V, et al. “Comparison of Two-dimensional Synthesized Mammograms versus Original Digital Mammograms Alone and in Combination with Tomosynthesis Images.” Radiology. 2014 Jun;271(3):664-71. Epub 2014 Jan 21.
4. Bernardi D, Pellegrini M, Valentini M et al. “The STORM II (Screening with Tomosynthesis or Mammography II) Trial: Interim Comparison of Screen-reading Strategies in Population Breast Screening.” (Paper presented at the annual meeting of the Radiological Society of North America, Chicago, Il, December 2014).
5. Durand M, Raghu M, Geisel J, et al. “Synthesized 2D Mammography + Tomosynthesis: Can We See Clearly?” (Paper presented at the annual meeting of the Radiological Society of North America, Chicago, Il, December 2015).
6. Choi J, Han B, Ko E, et al. “Comparison with Two-Dimensional Synthetic Mammography Reconstructed from Digital Breast Tomosynthesis and Full Field Digital Mammography for the Detection of T1 Breast Cancer.” European Radiology. Epub 2015 Dec.
7. Woo O, Choi G, Shin H, et al. “Comparative Diagnostic Value of Two-dimensional Synthesized Mammogram and Conventional Full-field Digital Mammogram for Evaluation of Breast Cancer” (poster presented at the annual meeting of the Radiological Society of North America, Chicago, Il, December 2015).
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Reference:
1. FDA submissions: P080003, 2011; P080003/S001, 2013; P080003/S004, 2017; P080003/S005, 2017; P080003/S006, 2011; P080003/S008, 2019.
2. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014 Jun 25;311(24):2499-507.
3. Zuckerman SP, Conant EF, Keller BM, et al. Implementation of Synthesized Two-dimensional Mammography in a Population-based Digital Breast Tomosynthesis Screening Program. Radiology. 2016 Dec;281(3):730-736.
4. Skaane P, Bandos A, Eben EB, et al. Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Radiology. 2014 Jun;271(3):655-63.
5. Bernardi D, Macaskill P, Pellegrini M, et. al. Breast cancer screening with tomosynthesis (3D mammography) with acquired or synthetic 2D mammography compared with 2D mammography alone (STORM-2): a population-based prospective study. Lancet Oncol. 2016 Aug;17(8):1105-13.
6. McDonald ES, Oustimov A, Weinstein SP, et al. Effectiveness of Digital Breast Tomosynthesis Compared With Digital Mammography: Outcomes Analysis From 3 Years of Breast Cancer Screening. JAMA Oncol. 2016 Jun 1;2(6):737-43.
7. Rafferty EA, Durand MA, Conant EF, et al. Breast Cancer Screening Using Tomosynthesis and Digital Mammography in Dense and Nondense Breasts. JAMA. 2016 Apr 26;315(16):1784-6.
8. Hologic data on file: DHM-05051_002
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Reference:
1. Results from Friedewald, SM, et al. “Breast cancer screening using tomosynthesis in combination with digital mammography.” JAMA 311.24 (2014): 2499-2507; a multi-site (13), non-randomized, historical control study of 454,000 screening mammograms investigating the initial impact the introduction of the Hologic Selenia® Dimensions® on screening outcomes. Individual results may vary. The study found an average 41% (95% CI: 20-65%) increase and that 1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1000 screening exams were found in women receiving combined 2D FFDM and 3D™mammograms acquired with the Hologic 3D Mammography™ System versus women receiving 2D FFDM mammograms only.
2. Zuley M, Guo B, Catullo V, et al. “Comparison of Two-dimensional Synthesized Mammograms versus Original Digital Mammograms Alone and in Combination with Tomosynthesis Images.” Radiology. 2014 Jun;271(3):664-71. Epub 2014 Jan 21. 9. Durand M, Raghu M, Geisel J, et al. “Synthesized 2D Mammography + Tomosynthesis: Can We See Clearly?” (Paper presented at the annual meeting of the Radiological.
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Reference:
1. 2021 Inspired Health Brevera Pulse: Wave 3 Research Report. Hologic Data on File.
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Reference:
1. FDA PMA P080003/S006, 2017
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Reference:
1. FDA PMA approval P080003/S006, 2017
2. Clinical Summary: DHM-00501, 2009, Hologic Data on File.
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Reference:
1. FDA submission: P080003, 2019; P080003/S001, 2013; P080003/S004, 2017, P080003/S005, 2017; P080003/S006, 2011.
2. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014 Jun 25;311(24):2499-507.
3. Results from Friedewald, SM, et al. “Breast cancer screening using tomosynthesis in combination with digital mammography.” JAMA 311.24 (2014): 2499-2507; a multi-site (13), non-randomized, historical control study of 454,000 screening mammograms investigating the initial impact the introduction of the Hologic Selenia® Dimensions® on screening outcomes. Individual results may vary. The study found an average 41% (95% CI: 20-65%) increase and that 1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1000 screening exams were found in women receiving combined 2D FFDM and 3D™ mammograms acquired with the Hologic 3D™ Mammography™ System versus women receiving 2D FFDM mammograms only.
4. Zuley M, Guo B, Catullo V, et al. “Comparison of Two-dimensional Synthesized Mammograms versus Original Digital Mammograms Alone and in Combination with Tomosynthesis Images.” Radiology. 2014
Jun;271(3):664-71. Epub 2014 Jan 21.
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Reference:
1. Selenia Dimensions MDR Technical File (TFS-00041), 2023.
2. Clinical Study Report: CSR-00116, 2019, Hologic Data on File.
3. Physician Labelling: MAN-06153, 2019.
4. FDA PMA Approval: P080003/S008, 2019.
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Reference:
1. VAR-06825 Attachment 5.2
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Reference:
1.K023398, K041226, K042480, K130277 (AFF), K113356(VAT), K103265(Whole Body), K072847 (AAC), K060111 (AAC)
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Reference:
1.Padoan M, Ferrante D, Pretti G, Magnani C. Study of socio-economic characteristics, diagnosis and outcome of women participating or not participating in mammogram screening. Ann Ig. 2014;26(6):518–526
2.Mendat CC, Mislan D, Hession-Kunz L. Patient Comfort from the Technologist Perspective. Hologic WP-00112 Rev 001 (2016)
3.Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00019 Rev 003(2017)
4.FDA Submission P080003/S006.
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Reference:
1. Schrading S, Martine D, Dirrichs T, et al. “Digital Breast Tomosynthesis-guided Vacuum-assisted Breast Biopsy: Initial Experiences and Comparison with Prone Stereotactic Vacuum-assisted Biopsy.” Radiology. 2015 274:3, 654-662 E-pub 2014 Nov 12.
2. Smith A, Sumpkin J, Zuley M, et al. “Comparison of Prone Stereotactic vs. Upright Tomosynthesis Guided Vacuum Assisted Core Breast Biopsies.” (paper presented at the annual meeting for the Radiological Society of North America. Chicago, II, November 2014).
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Reference:
1. https://www.prnewswire.com/news-releases/hologic-announces-fda-clearance-and-commercial-availability-of-the-affirm-prone-biopsy-system-the-first-2d3d-imaging-guided-dedicated-prone-biopsy-system-300255079.html
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References:
1. FDA clearance: K201019, K221449, K230096
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References:
1. Pattern classification of ShearWave™ Elastography images for differential diagnosis between benign and malignant solid by Mitsuhiro Tozaki and Eisuke Fukuma (Published: December 1st 2011: DOI: 10.1258/ar.2011.110276)
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References:
1. FDA Submission: K042290, 2004.
2. Internal testing performed at Hologic and maintained in PLM system. Cycle Time Test Report: TRP_20011_054, Hologic Data on File
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Barcode Scanner Option


Eliminate the need for manual entry by quickly and easily preparing patients for their exam with the under the table barcode scanner, saving time and accelerating workflow.*


*Option with additional purchase
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Configurable for your needs


Easily transition from screening to diagnostic exams or biopsy. Hologic offers cost-effective, space-saving, and ergonomic ways to expand your range of services. Connectivity options improve communication and workflow.
SmartCurve® breast stabilization system’s* curved compression surface mirrors the shape of a woman’s breast and distributes pressure more evenly to reduce pinching.
Dimensions Advanced Connectivity license* provides Modality Performed Procedure Setup (MPPS) to report the current state of an exam and Radiation Dose Structure Report (RDSR) capabilities to send dosage to third party applications.
Dimensions Notices license* provides communication between the technologist at the AWS and the radiologist at the SecurView® workstation.



*Option with additional purchase
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Control panel with
SonicPad® touchpad


The SonicPad® touchpad is designed to be ergonomically efficient, reducing examination time and user’s overuse fatigue and injury. This multi-touch touchpad and display work well with the use of gloves and gel, to help maximise efficiency and exam time as the user utilizes the shortcut gestures and application specific user interactions.
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Dynamic Display


Position 2MP or 3MP color display monitor to optimize viewing with dual articulating swing-arm and monitor tilt and swivel.*


*Option with additional purchase
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Ease of manual decompression


Designed to enable technologists to manually compress the breast while positioning the patient, with less strain on the wrist.
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Hands Free Imaging Option


The large, well-located foot pedal offers hands-free exposure control, helping to reduce any strain placed upon the hand and wrist due sustained presses. Activate the image exposure with just the press of a foot pedal, reducing fatigue and staying safely shielded at the same time.*


*Option with additional purchase
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LCD Controls


Intuitive touchscreen with straightforward icons and controls allowing the user to navigate through exams quickly and easily.
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Large source to image distance (SID)


Ample working space for interventional procedures.
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Linear grid assembly


Over time, the evolution of image processing has resulted in multiple hardware and software enhancements. As such, the gantry system includes a linear grid assembly without compromising on image quality and workflow as a result of the increased dynamic range.
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Selenia® Dimensions® Acquisition Workstation


Hologic’s Acquisition Workstation (AWS) is designed to streamline workflow and improve productivity. Features depend on the Dimensions® primary system configuration.
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Smart Positioning in MLO
(mediolateral oblique)


3Dimensions® includes MLO smart positioning, which moves the tube head +/- 15 degrees in the opposite direction in which the C-arm is positioned, to allow the technologist greater access to the breast for easier positioning and improved workflow.
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Standard resolution tomosynthesis


Only the Genius™ 3D Mammography™ exam is FDA approved as superior for women with dense breasts compared to 2D alone.¹𝄒² Genius 3D Mammography exams are more accurate than conventional 2D mammograms, detecting 20-65% more invasive breast cancers³ Combine with C-View™ synthesized 2D imaging to reduce dose and patient time under compression.⁴
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SureCare® Service


SureCare service ensures our customers can deliver the best possible patient experience, uninterrupted – because your peace of mind is what matters most.


Maximum uptime guarantee so you never have to put your work – or your patients – on hold.


Predictive analytics so we can address equipment issues before they even occur.


State-of-the-art connectivity so we can provide real-time insights on how to optimize business and clinical outcomes.


Passionate, trusted and engaged engineers who deliver exceptional service.
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15.6” Full HD touch display


• Large 15.6" HD touch display
• Flexibility to define your workflow
• Designed to work with gloves and gel



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23” FHD Monitor


Image uniformity, deep blacks and refined detail.
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3DQuorum®
imaging technology


3DQuorum imaging technology utilizes AI analytics to uniquely reconstruct high-resolution 3D™ data to produce 6mm SmartSlices. Designed to accelerate reading time, 3DQuorum technology reduces the number of images to review with no compromise in image quality, sensitivity or accuracy.¹˒² Provide the same clinical performance, faster compared to standard Hologic 3D™ imaging.¹⁻⁴
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3Dimensions™
Mammography System


Reveal fine details with the fastest, highest resolution 3D mammography exam using our advanced detector and innovative 3D imaging technologies designed to help detect more invasive cancers with confidence. With the integration of additional AI-powered solutions, the 3Dimensions is the smart, comprehensive platform supporting breast cancer detection, workflow optimisation and risk assessment.
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3Dimensions™
Mammography System


Reveal fine details with our fastest, highest resolution 3D mammography™ exam.¹⁻⁸ Our advanced and innovative 3D™ imaging technologies are designed to help detect 20-65% more invasive breast cancers compared to 2D alone.² With the integration of additional AI-powered solutions, the 3Dimensions system is the smart, comprehensive platform supporting best-in-class detection and diagnostics delivered with speed and accuracy.¹⁻⁸
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3Dimensions™ Acquisition Workstation


Hologic’s Acquisition Workstation (AWS) is designed to streamline workflow and improve productivity. Features depend on the Dimensions® primary system configuration, including a two- or three-megapixel medical grade DICOM color monitor, one-touch controls, biometric login, power memory height adjustment.
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A Modernized Hologic 3D™ Mammogram on the Envision Platform


A Welcome Screen greets each patient by name as a personalized touch to the exam designed to enhance the patient’s experience. And the displayed essential patient information offers a second reassurance for the technologist.


The Highspeed 3D Exam: The industry's fastest 3D scan at 2.5⁵ seconds helps minimize patient motion across all breast thicknesses without increasing dose. *𝄒¹𝄒⁵


Inclusive Communication: Selectable breathing prompts provide clear audio instructions in over 15 languages, providing an inclusive experience for all patients regardless of language barriers.


Relaxing Lighting: These premium details may enhance the imaging environment to support a calming and inviting experience for all patients.


Improved Patient Comfort 70% of women report that compression is more comfortable on the Envision™ platform compared to standard of care.² Plus, the proven SmartCurve® system offers improved patient comfort compared to standard compression.³
*Compared to systems with longer scan times.
References: 1. Hologic data on file. DHM-13391. 2. Hologic data on file. DHM-16430. 3. Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00119 Rev 003 (2017). 4. Based on an internal survey of 506 Radiologists, 367 Technologists, and 147 Executive Leaders from imaging centers globally. Inspired Health, May 2024. Unpublished internal Hologic data on file. 5. Smith, A. Tushita, P. Improving Tomosynthesis Image Quality using Advanced X-ray Technologies Hologic WP-00300 (2024)





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AI Powered Solutions


Discover the Hologic suite of integrated, future proofed AI solutions, to improve early detection and diagnosis of breast cancer, help to accelerate workflow, and enable personalised patient care, with automated breast density assessment.
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ATEC® Biopsy Needle


Designed for compassionate patient care, the system delivers large, consistent, quality cores with fewer needle insertions.
• Deliver uninterrupted local anaesthetic.
Combination of saline lavage and consistent aspiration helps ensure a core with every cycle.¹
• Totally closed system. Setup in less than one minute. No programming required.
• Tissue acquisition occurs every 4.5 seconds with a single insertion and clearly visible aperture.²
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ATEC® breast biopsy and excision system


One user-friendly console for every modality, with specific handpieces for each.


FastSetup in less than one minute, no programming required.


SafeFully closed system reduces contamination risk.


SimpleOne user-friendly console for every modality.



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Abdominal Aortic Calcification


The HD IVA scan allows a clinician to visualize calcified plaque in the abdominal aorta, which may be a significant indicator of coronary heart disease – the leading cause of death in women today.¹⁻³


Standard feature on A, W and C models.


Reference:
1. Wilson et al. Abdominal Aortic Calcific Deposits Are an Important Predictor of Vascular Morbidity and Mortality. Circulation. 2001; 1529-1534.
2. Hollander et al. Comparison between Measures of Atherosclerosis and Risk of Stroke: The Rotterdam Study. Stroke. 2003; 2367-2373
3. NIH, NHLBI Obesity Education Initiative. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults.
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Adapting to Your Workflow


Auto-MLO is intelligently engineered for less clicks with expanded patient access. During the rotation, the tube-head will trail behind the C-arm by 15-degrees to maximize patient positioning area. This flexibility combined with intelligent automation offers the technologist critical finetuning to position all patients effectively, even in high-volume, high-pace environments.


Angle memory: For reproducibility in both lateralities, angle memory can be used to replicate the angle and tilt for the opposite laterality.



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Adjustable Bracket


Fully adjustable backrest from 0 to 90 degrees to allow upright and decubitus positioning.
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Adjustable Components


Shoulder segments, arm support and headrest adjust for support during decubitus positioning.
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Adjustable Height


The bi-directional elevating table assembly is designed to improve clinician efficiency and patient comfort. The motorised height range of the patient support platform is 86.4 – 145 cm (34 – 57 in).
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Adjustable Trajectory –
Fully integrated lateral
needle approach


Switch between standard and lateral needle approach with the touch of the screen and with no additional attachments needed.
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Adjustable face shield


Retractable for ease of positioning, stationary during the exam.
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Advanced Body Composition® with visceral fat assessment


A comprehensive way to measure body composition, providing % body fat, total lean mass, bone density, limb comparison for muscle asymmetry, visceral fat and more. Standard feature on Wi, W and A models.
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Advanced Touchscreen and Control Panel


Control Panel and interactive displays provide essential patient and positioning metrics at your fingertips for smarter, more connected patient care. The dual panels offer access to the same controls available on the compression arm, allowing for seamless operation and flexibility. Each panel includes an emergency stop button, an advanced touchscreen and control buttons.


Control Buttons: Motion commands from the panel require a sequence of button presses to activate, preventing unintended movements.


Zero-all: Enabled from the Touchscreen and the Motion Command button, this will bring the C-arm tilt and rotation to zero.


Advanced Touchscreen: This touchscreen allows for viewing patient prior DICOMs or access procedure views to modify workflow on the fly. Within Settings, access four ambient lighting colors to set desired lighting and mood. Audible breathing prompts can be chosen here and enabled from the AWS.


Prior Display and Information: The platform can display multiple prior views simultaneously (4-in-1,) providing a comprehensive reference for current imaging. Includes specific details such as angle and tilt information from previous sessions, aiding in consistent imaging outcomes.


Activate Procedure View Icons: The platform integrates view icons associated with patient procedures, allowing quick access and activation. Upon selection it can bring up predictive angle based on CC or MLO. This is especially useful for on-the-fly adjustments while positioning the patient.
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Affirm® Lateral Arm


Confidently target challenging lesions and biopsy thinly compressed breasts with the lateral arm accessory for Affirm® upright biopsy guidance system. This versatile, easy-to-use device enables needle access parallel to the detector – from either the lateral left or lateral right position. Choose the optimal approach based on each patient’s anatomy and lesion location to accelerate and simplify biopsy procedures.
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Affirm® breast biopsy guidance system


The Affirm biopsy guidance system offers the flexibility to conduct 2D or 3D breast biopsies in the same modality as imaging. This biopsy device add-on works seamlessly with the Hologic Dimensions systems with average procedure time of less than fifteen minutes.¹𝄒² A cost effective, space-saving, and ergonomic way to help deliver a fast biopsy procedure for compassionate patient care.
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Affirm® prone biopsy
guidance system


The Affirm prone biopsy system was the first dedicated prone biopsy system to offer both 2D and 3D™ imaging-guided breast biopsies.¹ The biopsy system provides exceptional 2D imaging capability and is upgradeable to 3D imaging. This next-generation solution elevates prone biopsy performance by delivering superior imaging, a proven faster and streamlined workflow compared to the Hologic MultiCare Platinum System, and total 360° access to the breast.
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Akrus™ Mammography
Positioning Chair


The Akrus™ chair is versatile and ergonomically designed for screening, diagnostic and biopsy imaging. It allows a variety of positioning options including upright and decubitus in all mammography projections including magnification views. The Akrus chair is a valuable addition to any facility.
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All breast optimised transducers for imaging


LH20-6 Superficial lesions and retro-areolar region
L18-5 Subtle anatomical details
L10-2 Great depth
LV16-5 Acquisition of 3D volumes
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Ambient mood lighting


Premium details like ambient mood lighting foster an inviting and calming experience for patients.
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Angled Biopsy Device Mount


Fixed 10-degree angle ensures mount does not obscure view and helps with posterior lesion access.
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Atypical Femur Fracture Assessment scan


Assess potential atypical femur fractures with radiographic quality images of the entire femur. A quick, 15-second scan reveals cortical thickening of the bone, making it fast and easy to monitor the effects of bisphosphonate therapy over time.¹
Standard feature on A, W and C models.


Reference:
1. FDA Submission: K130277, 2013.
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Barcode Scanner


Eliminate the need for manual entry by quickly and easily preparing patients for their exam with the under the table barcode scanner, saving time and accelerating workflow.
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BioZorb® 3D bioabsorbable marker


Unique open spiral design
Provides stable geometry for permanent marker clips in 3D array.


Bioabsorbable spiral
Designed to be absorbed by the body over several years.


Six titanium marker clips
Designed to provide permanent identification of the surgical site and enable image-based tracking of the surgical cavity for radiation treatment planning and follow-up.


References.
1. Kaufman CS, et al. Clinical use of a three-dimensional tissue marker to target post lumpectomy radiation. J Clin Oncol 33, 2015 (suppl 28S; abstr 53).
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Biopsy Hard to Detect Lesions.


Affirm® Contrast Biopsy software allows clinicians to target and acquire tissue samples in lesions identified with contrast enhanced mammography (CEM) where a correlate may not be found on a FFDM, DBT or ultrasound image.


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Braking System


Three-point braking system.
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Breast Dedicated Reading Workstation


SecurView® diagnostic workstation, designed by radiologists for radiologists, offers flexible, interactive, and comprehensive mammography and tomosynthesis tools. With the added ability to read breast ultrasound and MRI images all from the comfort of home, SecurView is created to simplify and optimize the diagnostic workflow.
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Brevera® breast biopsy system


An all-in-one solution, that combines tissue acquisition, real time imaging, verification and advanced tissue handling designed to provide a positive patient and physician experience.
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Built to Tilt


Envision mammography platform is built to tilt, so it adapts to patients of more body types and abilities.
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C-View™ standard-resolution synthesized 2D imaging technology


C-View imaging technology takes tomosynthesis data and instantly generates 2D images designed to enhance details such as bright spots and linear structures. With a rapid 3.7 second continuous scan (regardless of breast thickness), the low dose Genius™ 3D Mammography™ exam is designed to minimize the risk of patient motion, provide a comfortable patient experience, and deliver proven superior clinical performance compared to 2D mammography for all breast types.¹⁻⁷
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Celero® vacuum-assisted breast biopsy device


Untethered Freedom
The industries first spring-loaded core device with integrated vacuum technology was designed for more control, consistent cores, and better access.
Make Fewer insertions for accurate diagnosis with cores more than two times larger than other 14G SLC devices.¹
Designed to ensure large samples and consistent cores with the first spring-loaded core device with integrated vacuum technology.²
Confidently approach challenging lesions:
11-degree trocar tip for smooth penetration
10mm dead space
Option to fire outside the breast for no throw
insertion and clearly visible aperture.
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Compact Size


The Insight FD is flexible, lightweight, and compact allowing to easily move from room to room. The system folds into a tight mobile package for quick and efficient storage.
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Comprehensive Imaging Package


Hologic’s Comprehensive Imaging Package is setting a new standard of breast imaging and elevating your high-resolution imaging environment with Genius® AI solutions.*


High resolution imaging: Without increasing patient dose, our proprietary acquisition pathway offers a 2.5-second 3D scan time, generating our fastest, sharpest high-resolution (70µm) images ever, compared to the 3Dimensions system and ClarityHD+ imaging.¹⁻³𝄒⁶𝄒⁷𝄒⁹ The Envision platform comes with a standard comprehensive imaging package, including: Intelligent 2D™ advanced synthetic imaging, 3DQuorum technology and a Genius AI detection solution.*


Save up to an average of 1-hour of interpretation time per day (based on 8 hours interpretation time)⁶𝄒⁸ with 3DQuorum® technology.


Only the Hologic 3D™ mammogram detects more invasive breast cancers compared to 2D alone.⁴ Plus, only the Hologic 3D mammography exam is FDA approved as superior for women with dense breasts compared to 2D alone.⁵𝄒⁶


* Genius AI Detection 2.0 and PRO Software on the Envision Platform are pending 510(k) clearance with the US FDA.


References: 1.Hologic data on file: DHM-16158 2. Hologic data on file: DHM-14517 3. Hologic data on file: VER-12082 (1.0) 4. 4. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014 Jun 25;311(24):2499-507 5. FDA submissions P080003, P080003/S001, P080003/S004, P080003/S005, P080003/S009 6. FDA Submission: P080003/S009 7. Hologic data on file: DHM-13391 8. Report: CSR-00116 9. Hologic data on file: VER-12160 (1.0)
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Control Panel and the Advanced Touchscreen


The dual Control Panels provide essential patient and positioning metrics at your technologist fingertips for smarter, more connected patient care. Offering access to the same controls available on the compression arm, the panels allow for seamless operation and flexibility.


At the Advanced Touchscreen, now review patient prior views simultaneously (4-in-1) as a quick reference during imaging. Or access integrated procedure views to modify workflow on the fly. Then, within settings, select relaxing lighting colors to set the desired mood or enable audible breathing prompts.



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Control panel with
SonicPad® touchpad


The SonicPad® touchpad is designed to be ergonomically efficient, reducing examination time and user’s overuse fatigue and injury. This multi-touch touchpad and display work well with the use of gloves and gel, to help maximise efficiency and exam time as the user utilizes the shortcut gestures and application specific user interactions.
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Control panel with
SonicPad® touchpad


The SonicPad® touchpad is designed to be ergonomically efficient, reducing examination time and user’s overuse fatigue and injury. This multi-touch touchpad and display work well with the use of gloves and gel, to help maximise efficiency and exam time as the user utilizes the shortcut gestures and application specific user interactions.
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Control panel with
SonicPad® touchpad


The SonicPad® touchpad is designed to be ergonomically efficient, reducing examination time and user’s overuse fatigue and injury. This multi-touch touchpad and display work well with the use of gloves and gel, to help maximise efficiency and exam time as the user utilizes the shortcut gestures and application specific user interactions.
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Control panel with
SonicPad® touchpad


The SonicPad® touchpad is designed to be ergonomically efficient, reducing examination time and user’s overuse fatigue and injury. This multi-touch touchpad and display work well with the use of gloves and gel, to help maximise efficiency and exam time as the user utilizes the shortcut gestures and application specific user interactions.
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Control panel with
SonicPad® touchpad


The SonicPad® touchpad is designed to be ergonomically efficient, reducing examination time and user’s overuse fatigue and injury. This multi-touch touchpad and display work well with the use of gloves and gel, to help maximise efficiency and exam time as the user utilizes the shortcut gestures and application specific user interactions.
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Control panel with
SonicPad® touchpad


The SonicPad® touchpad is designed to be ergonomically efficient, reducing examination time and user’s overuse fatigue and injury. This multi-touch touchpad and display work well with the use of gloves and gel, to help maximise efficiency and exam time as the user utilizes the shortcut gestures and application specific user interactions.
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Control panel with
SonicPad® touchpad


The SonicPad® touchpad is designed to be ergonomically efficient, reducing examination time and user’s overuse fatigue and injury. This multi-touch touchpad and display work well with the use of gloves and gel, to help maximise efficiency and exam time as the user utilizes the shortcut gestures and application specific user interactions.
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Control panel with
SonicPad® touchpad


The SonicPad® touchpad is designed to be ergonomically efficient, reducing examination time and user’s overuse fatigue and injury. This multi-touch touchpad and display work well with the use of gloves and gel, to help maximise efficiency and exam time as the user utilizes the shortcut gestures and application specific user interactions.
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Control panel with
SonicPad® touchpad


The SonicPad® touchpad is designed to be ergonomically efficient, reducing examination time and user’s overuse fatigue and injury. This multi-touch touchpad and display work well with the use of gloves and gel, to help maximise efficiency and exam time as the user utilises the shortcut gestures and application specific user interactions.
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Control panel with
SonicPad® touchpad


The SonicPad® touchpad is designed to be ergonomically efficient, reducing examination time and user’s overuse fatigue and injury. This multi-touch touchpad and display work well with the use of gloves and gel, to help maximise efficiency and exam time as the user utilizes the shortcut gestures and application specific user interactions.
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DB SYNC and IRIS-Enterprise


Maintain master database of raw data and sync connected systems in real time with DB SYNC.


IRIS-Enterprise Connectivity Suite
Achieve raw data to PACS, share data across systems.
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Dedicated Technologist Screen


An intuitive interface allows for a guided system setup, visualization of cycles completed, and troubleshooting guidance so you know where you are in the process, always.
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Don’t Let Clarity Slow You Down


Hologic’s newest proprietary 3D acquisition, featuring Focusing Technology, counteracts the motion of the highspeed scan and stabilizes the focal point for sharp, in-focus imaging. ¹⁻³


The first-ever FDA-approved mammography innovation of its kind** is designed to bring clarity to all patient exams and confidence to all radiologists.²


In turn, the patented engine boosts image sharpness, achieving an average 19% improvement at 6cm and a remarkable 42% improvement at 8cm above the detector plate without increasing dose.*,¹⁻³


* Compared to 3Dimensions high-resolution imaging
** FDA PMA Approval P080003/S009, 2024


References: 1. Based on an internal survey of 58 Patients and 7 Technologists. Inspired Health, November 2023. Unpublished internal Hologic data on file. 2. Data on file: DHM-16158 3 Data on file: DHM-14517
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Duo System
localisation wires



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Dynamic Display


The double-articulating swing arm enables you to easily adjust the angle and position of the image monitor. This monitor display can be tilted and inclined to optimize your view of images. The combination of both movements helps to reduce physical strain on the neck, while attending to your patient. The articulating arm is particularly useful when performing biopsy procedures.
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Ease of manual decompression


Designed to enable technologists to manually compress the breast while positioning the patient,
with less strain on the wrist.
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Electronic Lift


2 Rechargable batteries included, no electric cord needed - 330lbs/150kg (lift) - 1200lbs/544kg (static).
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Equitable Clarity


Today, more than 1 out of 10 patients exhibit limited mobility that may result in poor imaging or longer, and possibly frustrating, exams.³


Finally prioritize equitable clarity and care with a platform designed with inclusivity top of mind. Provide technologists customizable tools for technologists to screen extensive patient types such as kyphotic, frozen shoulder, extreme body habitus, wheel-chair users or limited mobility—for more inclusive accessible care.¹𝄒²


Millimeters matter. +/-10° tilt rotation in all views. It is engineered to unlock a new perspective on patient positioning and yield high-quality imaging. In addition, tilt may help improve positioning of patients with limited mobility — for more inclusive, accessible care.²𝄒³


References
1. Centers for Disease Control and Prevention. (2018a). Disability and health data system. (2021) 2. Agaronnik, N. D., El-Jawahri, A., & Iezzoni, L. I. (2022). Implications of Physical Access Barriers for Breast Cancer Diagnosis and Treatment in Women With Mobility Disability. Journal of Disability Policy Studies, 33(1), 46-54. 3. Based on an internal survey of 506 Radiologists, 367 Technologists, and 147 Executive Leaders from imaging centers globally. Inspired Health, May 2024. Unpublished internal Hologic data on file.


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Ergonomic C-Arm


Designed to offer positioning flexibility with a rotating detector, C-arm depth of 20”, and 120° forward and back orbital rotation.
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Ergonomics


Monitor touchscreen movement, touch display, control panel and height adjustment.
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Eviva® breast biopsy system


Fast:
Remove cores every 4.5 seconds.¹
Easily, confidently, and accurately deploy the biopsy site marker using the integrated introducer sheath and end-deploy markers.


Compassionate:
Manage patient pain with local anaesthetic directly to the biopsy site with every core with patented Y-valve.²
Manage patient bleeding without stopping the procedure with saline lavage and constant aspiration.
Quiet, remote firing and local anaesthetic delivered directly to the site each cycle, without interrupting the procedure.³


Easy:
Optimize access to challenging lesions close to the chest wall using a low-profile needle.
Manage thin breast compressions as small as 16mm.⁴
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Exceptional Image Quality


Designed to generate distortion-free images with a high sensitivity CsI CMOS detector and advanced image processing algorithm. The system allows larger anatomy imaging with dose optimization.
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FAST Paddle™ technology


Allows the paddle to flex with the flip of a button to help maintain uniform compression.
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FRAX® 10-year fracture risk assessment


Integrated into APEX software and printed on reports is the 10-year fracture risk assessment using the classifications of fracture risk defined by the FRAX® tool.¹


References:
1. Horizon Technical Reference Manual MO3648: page 105 for FRAX™
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Faxitron® Core
specimen radiography system


Confirmation in the room.
Within seconds this self-contained, tabletop unit provides high-resolution imaging for immediate core sample verification in the biopsy room.
Displayed on a 24” high resolution 3.7MP monitor, the Faxitron Core system sends multiple annotated images to PACS at the touch of a button.
Faxitron Core system is also known as the CoreVision® system.



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Faxitron® Path specimen radiography system


With a large field of view and high-resolution detector the Faxitron Path system is designed to help you deliver efficiency and exceptional patient care.


Important Safety Information
Faxitron PathPlus is a cabinet digital x-ray imaging system indicated for use to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Please review the Instructions for Use for warnings and precautions pertaining to the use of this device.





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Faxitron® Path+ specimen radiography system


With a large field of view the Faxitron Path+ system is designed to help deliver efficiency for the gross lab and results for patients.


Important Safety Information
Faxitron PathPlus is a cabinet digital x-ray imaging system indicated for use to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Please review the Instructions for Use for warnings and precautions pertaining to the use of this device.



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Faxitron® Trident® HD specimen radiography system


Improved workflow
Streamline workflow with in-room imaging that can provide immediate verification of the target tissue right in the procedure or operating room without transporting tissue, and no waiting for margin confirmation or scheduling delays.


Exceptional Image Quality
Trident HD takes advantage of amorphous selenium direct capture imaging to generate crisp, sharp, and high-resolution images provided to the user for accurate and rapid sample verification on the spot.


Robust & compact design
The compact system’s mobility makes it easy to transport from room to room or move closer to the procedure.


Important Safety Information
Trident HD is a cabinet x-ray system indicated for use to provide digital x-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure. Please review the Instructions for use for warnings and precautions pertaining to the use of this device.
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Field Light improvements


During both needle localization and Affirm® Upright biopsy procedures, the length of time in which the field light remains on has been extended to about 10 minutes. This enhancement is designed to improve workflow for the radiologist during diagnostic procedures, to allow for more focus on what matters
most – The Patient.
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Fingerprint Scanner
(Biometric Login)


Use your fingerprint to login. Easily switch between operators without closing the patient.
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Flat Work Surface


Streamline exams and accelerate workflow with this fully equipped acquisition workstation with fingerprint user identification, powered height adjustment, stowable keyboard drawer emergency buttons, X-ray exposure button and LCD touchscreen monitor.
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Flexible Dual Monitors


With swivel, rotation, tilting and adjustable heights, the Brevera® Breast Biopsy System monitors provide the flexibility to meet your preference with customizable configuration.
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Fluoroscan® InSight® FD
mini C-arm


The Fluoroscan InSight FD Mini C-arm is designed to overcome the challenges of extremity imaging. Tailored to meet your needs with simple, intuitive operation and excellent image quality, the system provides control, confidence and procedural efficiency. It’s the ideal extremity imaging solution for surgical procedures in the Hospital OR, Ambulatory Surgery Center or diagnostic imaging support in a busy Emergency Department, Orthopedic Clinic or Private Office.



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Foot Display


Real-time display for key tech metrics enabling precise and informed patient positioning. Such metrics include the compression arms rotation and tilt angle. Additionally, the screen will automatically rotate for easy viewing and to provide continuous, visible feedback to the technologist.


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Foot Switch


The large, precisely located foot pedal offers hands-free exposure control, helping to reduce any strain placed upon the hand and wrist due sustained presses. Activate the image exposure with just the press of a foot pedal, reducing fatigue and staying safely shielded at the same time.
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Fully Automated Tube
Head Motion


Tube head is automated, eliminating any manual positioning and allowing imaging to be generated in a matter of seconds. Capture all images with a single button press.
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Gantry side buttons


The additional C-arm controls on the side of the gantry are designed for an improved workflow, by allowing the technologist to easily move the C-arm away from or towards them, without unnecessarily bending or reaching, to avoid work-related injuries.
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Genius AI® Detection solution


Building on Hologic’s history of technical innovation and commitment to saving the lives of women, Genius AI Detection solution represents the next breakthrough in helping radiologists identify breast cancers. Using deep learning technology, Genius AI Detection solution is designed to find cancers in tomosynthesis studies with improved accuracy as compared to Hologic’s previous generation CAD, with the software fully integrated on the 3Dimensions® system.¹


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HD Instant Vertebral Assessment™
(IVA) assessment scan


Patients with a previous vertebral fracture are at higher risk for future fractures.¹ Assess fracture risk by combining an accurate measurement of bone density with high-resolution vertebral imaging with a low-dose image in 10 seconds.²


Standard feature on A, W and C models


Reference:
1. https://link.springer.com/article/10.1007/s00198-021-05900-y. Published 4.28.22. Last accessed December 2022.
2. Identify Spine Fractures: MAN-04871 Rev 005 (02/2017) Horizon Bone Densitometry System User Guide dose and speed: MAN-03283 Rev 006 (03/2016) QDR Series X-Ray Bone Densitometer Technical Specifications Manual



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High Resolution Evolution:


Quantra 2.2 software is a machine-learning algorithm that analyses each patient's pattern and texture to provide an unbiased breast density assessment through a four-point scale based on Bi-RADS, Fifth Edition. Quantra software is integrated on the acquisition workstation to facilitate high-risk/density-based patient management protocols for potential supplemental imaging.
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Hologic Clarity HD®
high-resolution tomosynthesis technology


Hologic Clarity HD Technology is a 3D™ algorithm that enables the full detector readout resulting in consistent 70-micron high resolution tomosynthesis images. Designed to increase diagnostic confidence by delivering exceptional 3D images that clearly reveal subtle lesions and the fine calcifications, regardless of breast size or density.¹


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Hologic Envision™ Mammography Platform


Envision seeks to deliver on three core values:


1. Best-in-class imaging: Powered by patented technology, experience high-resolution imaging solutions, enhanced by Genius AI® detection software, for our fastest sharpest HD images.
Ever *𝄒 **𝄒 ¹⁻³


And with over two-decades of experience in AI
and breast analytics, Hologic is delivering a comprehensive package that now includes an integrated AI detection assistant. ‡


2. Individualized care: A platform that adapts to you—not the other way around. Because every mammogram is personal.


3. Optimized performance: Don’t let clarity slow you down. The new 2.5s highspeed 3D exam also offers imaging solutions to accelerate read times.³ ⁻ ⁵ Accelerate your everyday with consistent results




Genius Al Detection 2.0 is pending 510(k) clearance with the U.S. FDA
* Genius AI Detection 2.0 Software on the Envision Platform is pending 510(k) clearance with the US FDA
** Genius AI Detection PRO Software on the Envision Platform is pending 510(k) clearance with the US FDA


References:1. Hologic data on file: DHM-16158 2. Hologic data on file: DHM-14517
3. Hologic data on file: VER-12082 (1.0) 4. CSR-00116 5. FDA Submission: P080003/S009
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Horizon® DXA system


The Horizon DXA Platform offers more than just traditional bone density screening. This multi-faceted system is designed to help clinicians assess fracture risk probability, body composition assessment, and cardiovascular risk — critical elements that will help keep life in motion.¹
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I-View® 2.0 contrast enhanced digital mammography (CEDM)


I-View 2.0 contrast enhanced mammography (CEM) software is a simple upgrade to any Selenia® Dimensions® or 3Dimensions™ mammography system, giving breast imaging practices an efficient pathway to expanded diagnostic capabilities. CEM and contrast biopsy (CEBx) utilize familiar mammography equipment and workflow, allowing you to easily expand the scope of your practice with minimal investment.
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Image Prefetching and
Storage Solutions


Streamline your digital mammography workflow with the SecurXchange® Archive and SecurXchange Router helping increase patient throughput, improve data management and clinical practice efficiency.


SecurXchange Archive provides an efficient approach to handling the archiving requirements of tomosynthesis and multi-modality image data, for practices that do not have access to a PACS or need a local archiving solution. SecurXchange Router offers solutions to complex workflow needs, including pre-fetching of prior studies and intelligent routing of DICOM objects.
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Imaging Modes


B-mode image quality with incredible definition in both fundamental and harmonic imaging modes


ShearWave® PLUS elastography for real-time tissue stiffness evaluation in 2D and 3D


Angio PLUS imaging for microvascular flow assessment


Needle PLUS addresses the challenge of limited needle visibility and the need to predict the needle trajectory


TriVu imaging simultaneous acquisition of 3 essential characteristics
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Improved Core Handling


Tissue filter wheel and cap improvements to minimize core movement outside the intended chamber during transportation to pathology.
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Industry-leading Scan Time


Hologic is pushing the limits of x-ray tube technology such that speed of exam does not compromise image quality. We’re introducing a 33% faster scan time when compared to the Selenia® Dimensions® system and sharpened high-resolution imaging.*,¹⁻³
Discover the highspeed 2.5-second 3D™ exam scan time, only available on the Envision platform.
* Compared to 3Dimensions high-resolution imaging


References: 1. Data on file: VER-12082 2. Hologic data on file. DHM-16158
3. Hologic data on file. DHM-14157



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Integrated Reporting Solutions


Accelerate workflow with multiple types of reporting including Physicians DX reports.
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Integrated Storage


The streamlined compartment on the side may be used for a QC manual or notebooks while the front paddle rack allows for quick access to the technologist’s two most used paddles. Plus, an integrated pen holder is designed to organize the charting space.



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Intelligent 2D™
high-resolution synthesized
2D imaging technology


Intelligent 2D imaging technology retains more features of interest from 3D™ data than ever before
in comprehensive, high-resolution synthesized
2D images, compared to C-View™ imaging.¹ Intelligent 2D images enable radiologists to quickly and confidently appreciate subtle mammographic features and lesion morphology that are well correlated to the 3D data.¹ It is FDA approved to replace traditional FFDM, lowering dose and time under compression for your patient.²
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Internal Dynamic Calibration™ system


Pixel-by-pixel calibration through bone and tissue equivalents – contributing to scan reproducibility and precision over time for patient monitoring.¹ Standard feature in all models.


Reference:
1. Hangartner TN. A study of the long-term precision of dual-energy x-ray absorptiometry bone densitometers and implications for the validity of the least-significant-change calculation. Osteoporosis Int. 2006
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Intuitive 24” HD Color Touchscreen


HD touchscreen monitor with finger touch rotation, zoom, and color-directed functionality and customizable surgeon specific settings. View up to 12.4”x12.4” with MegaView™ Image.
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Intuitive Interface


The retractable, cleanable keyboard has blue backlighting and is designed for easy cleaning and easily replaceable via a USB port. Footswitch exposures are available, and hand exposures can be activated with a new, ergonomic finger grip on either side.
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Intuitive Interface


An intuitive user interface, real-time imaging, and automated specimen collection and separation, work together to save facilities an average of 12 minutes per biopsy procedure.¹
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Keep the Lights on with Service Excellence


The Envision platform utilizes advanced telemetry via Unifi(R) Connect to continuously track parts data with the goal of generating predictive analytics and minimizing downtime. Track 700+ new analytics parameters allowing for predictive service potential to save you from unnecessary downtime.*,¹,² Improved airflow for superior detector cleaning and protection.³ Now access 98% of system care from the front and side panels; designed for servicing efficiency and install flexibility, with only four inches of rear system access clearance required.⁴, ⁵


* Compared to Selenia Dimensions and 3Dimensions systems


References
1. Hologic data on file. SRS-01327; AT_02-REQ-17382 2. Hologic data on file. VER-13396. 3. U.S. Food and Drug Administration, Center for Device and Radiological Health. (2022, October 6). Genius AI Detection 2.0 K221449, K230096, 510(k) Summary. www.accessdata.fda.gov/cdrh_docs/pdf22/K221449.pdf. 4. Hologic data on file: VER-11685 5. Hologic data on file: MAN-08972
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Keyboard Tray


Retractable, cleanable keyboard. Desk light to illuminate critical tasks



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LOCalizer™
wire-free guidance system


Convenient Scheduling
Improve scheduling conflicts by implanting the RFID tag into the breast prior to the date of the surgery.


Distance Gauge in mm
The handheld Reader displays the distance to the tag in millimeters and the tag’s ID number on a bright screen, making it easy to read during the procedure.


Mobile Portability
Handheld Reader is suitable for use in both sterile* and non-sterile environments. It can be placed in convenient proximity to the patient.


*Reader must be bagged in sterile drape on skin surface in a sterile environment.
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Lateral Arm Attachment


The ability to attach the Lateral arm to both sides of the 3Dimensions System allows for flexibility and accuracy during the biopsy procedure.
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Lightweight X-ray
Translucent paddles


Lightweight X-ray translucent paddles are clear instead of metal, which increases the field of view beyond the biopsy window.
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Linear grid assembly


Over time, the evolution of image processing has resulted in multiple hardware and software enhancements. 3Dimensions™ system includes a linear grid assembly without compromising on image quality and workflow as a result of the increased dynamic range.
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Low noise level cooling fan


Optimised cooling fan architecture reduces noise for all environments.
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Lower patient dose


Highspeed 3D: A 2.5 second high-speed 3D scan, reducing possible patient motion.
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Maximum Comfort Package


Patient support platform memory-foam cushions and interchangeable apertures ensure optimal breast access while maximizing patient comfort.
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Monitors


The Envision Acquisition Workstation setup includes a wide-angle, high-resolution control monitor which can be tilted by the technologist to avoid glare. Plus, a 3MP image display monitor can be rotated from right to left for optimal viewing. Technologists can now review an embedded motion detection grid overlay for possible motion at point-of-care.




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MultiView™ multi-modality reading software


Expand the SecurView® workstation with MultiView multimodality capabilities and display Breast Ultrasound and Breast MRI together with mammography images. Multimodality image display synchronize mammography, ultrasound, and breast MR images to ensure that images from the same patient are automatically displayed when opening a patient.



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NHANES Reference Database


Over 20,000 individuals sampled by the CDC via the National Health and Nutrition Examination Survey. No conversion required as data was collected on Hologic equipment. Provides robust normative data for bone and body composition comparison.¹


References:
1.Kelly TL, Wilson KE, Heymsfi eld SB (2009) Dual Energy X-Ray Absorptiometry Body Composition Reference Values from NHANES. PLoS ONE 4(9): e7038. doi:10.1371/journal.pone.0007038
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OnePass™ technology


A digital high-resolution ceramic detector array is paired with true fan-beam acquisition geometry to enable rapid, dual-energy bone density measurements in a single sweep scan. Standard feature in all models.


No X-ray beam overlapping = unique data sampling -
No oversampling or undersampling - High-resolution images -
Fast scan times.
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OnePass™ technology


A digital high-resolution ceramic detector array is paired with true fan-beam acquisition geometry to enable rapid, dual-energy bone density measurements in a single sweep scan.¹


Standard feature in all models.



Reference:
1. FDA Submission: K023398, 2002.
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Or Foot Control



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Personalized Ergonomics


Compression Touchscreen: Not only are compression metrics displayed, but the technologist can also interact with the touchscreen. These real-time updates may enable accurate and consistent compression during imaging. Additionally, the display will automatically rotate for easy viewing and to provide continuous, visible feedback to the technologist.


Continuous Field Light for reliable visibility during the entire study duration.


Streamlined surface for expanded positioning access and a slimmer detector compared to the 3Dimensions system.



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Power Behind Innovations


Inspired by the gaming industry, SuperSonic® MACH® 30 is a software-based platform with exclusive UltraFast™ technology that brings almost unlimited possibilities into ultrasound imaging:
Excellent image quality
Evidence-based innovative imaging modes
Enabling future AI integration
Image acquisition up to 20,000 frames per second¹
UltraFast technology


No compromise, no comparison.
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Power of AI


Hologic’s 3D Genius AI solution¹* is designed to provide accurate markings, fast triaging tools, and optimized point-of-care results.¹⁻³ Envision mammography platform delivers 70μm high-resolution 3D imaging exam and intelligent AI-powered solutions for accurate and timely diagnoses.⁴⁻⁵



* Genius AI Detection PRO Software on the Envision Platform is pending 510(k) clearance with the US FDA.


References
1. FDA clearance K221449, K230096, K201019 2. WP-00178 3.CS-00376 4. Report: CSR-00116 5. FDA approval number.P080003/S009
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Powered Height Adjustment


The user can easily adjust the height of the acquisition workstation. A fast, silent motor simply adjusts the workstation height to the height preference of users, helping to reduce strain on lower back, arms, and wrists. Configurable height adjustment can be activated by biometric login and stored for each user reducing the number of steps required eliminating physical manipulation.
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Premium Acquisition Workstation


A state-of-the-art control center, personalized and optimized for each technologist. Featuring a modernized software interface, the AWS can automatically adjust to the technologist’s personalized requirements via a biometric fingerprint login. Plus, the system offers automatic height adjustment control and features a compression release, an emergency stop, a barcode scanner and more.
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Premium Acquisition Workstation


A state-of-the-art control center, personalized and optimized for each technologist. The system can adjust to the users’ personalized requirements via a biometric fingerprint login. The system offers upward and downward travel and features a compression release, an emergency stop, and a barcode scanner. These controls can be customized based on facility needs.


Integrated Storage: The storage on the side could be used for QC manual or notebooks. The front Paddle Rack storage allows for quick access to your two most used paddles.


Monitors: The Envision Acquisition Workstation setup includes a wide-angle, high-resolution control monitor which can be tilted to avoid glare. The 3MP image display monitor can be moved from right to left, and there will be a pen holder for unused space.


Interface: The retractable, cleanable keyboard has blue backlighting and is designed for easy cleaning and easily replaceable via a USB port. Footswitch exposures are available, and hand exposures can be activated with a finger grip on either side of the gantry.


Desk light is available for tabletop tasks like QC charting, balancing the patient experience while illuminating technologist tasks.


Embedded motion detection grid overlay for technologists to review possible motion at point-of-care





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Product name


Body copy
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Quantra™ 2.2 breast density assessment software


Quantra 2.2 software is a machine-learning algorithm that analyses each patient's pattern and texture to provide an automated breast density assessment through a four-point scale based on Bi-RADS, Fifth Edition. Quantra software results are directly available in the exam room to facilitate high-risk/density-based patient management protocols for potential supplemental imaging.
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Real-Time Core Imaging


Integrated specimen imaging and built-in image enhancement tools allow for real-time visualization of excised specimens and quick identification of faint calcifications.



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Reduced Footprint


System height adjustable from
109cm (43in) to 183cm (72in)


System depth adjustable from
99cm (39in) to 121cm (48in)


System width 60cm (24in)


Able to pass through a 70cm (28in) doorway
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Research Package


Options include: Infant Whole Body, Prosthetic Hip, Small Animal.
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Rotating C-arm


Exclusive to Horizon A systems - the only DXA system with a rotating C-arm allowing for supine IVA scans.
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Rotating Flat Detector


Designed to provide improved workspace access and the ability to change positioning +/- 90° without moving the C-arm, to best suit the anatomy and optimize detector length to minimize dose.



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SecurView®


SecurView ® diagnostic workstations, designed by radiologists for radiologists, offers flexible, interactive and comprehensive breast tools to simplify and optimise your diagnostic workflow.


Accelerate your reading time with the SecurView ® dedicated workflow keypad which enables single-button handing protocol advancement, protocol integrated analytic displays, and one-button exam completion. Examine all relevant 3Dimensions ™ studies, including priors, immediately and efficiently for fast, informed diagnostic decisions.
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Selenia® Dimensions® 3D™ Performance Mammography System


The Selenia® Dimensions® 3D™ performance mammography system delivers on the extraordinary promise of breast tomosynthesis. Genius™ 3D Mammography™ exams are more accurate than conventional 2D mammograms, detecting 20-65% more invasive breast cancers compared to 2D alone.¹ Combine with C-View™ synthesized 2D imaging to reduce dose and patient time under compression.²
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Sertera® spring-loaded core breast biopsy device


Exceptional control in a simple spring-loaded core device
Perfect for accessing difficult lesions, the device was designed to be lightweight and ergonomic thanks to our patented HandForm™ design.
Simple, one-handed operation with patented HandForm design:
Lightweight ergonomics comfortable for many hand sizes
Two firing modes for extra control when you need it
Approach challenging lesions with confidence.
7 out of 10 physicians felt the Sertera biopsy device resulted in greater accuracy
In an initial survey, 95% of physicians stated that the Sertera biopsy device was easy to arm and fire and allowed for one-handed operation
Nine out of ten physicians said – it is easy to use. ¹
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Simple Touchscreen Biopsy Controls – Touchscreen Biopsy Control Module


With automatic calculations, the biopsy needle parameters are programmed into the system to display safety margins and relevant distance in real-time. Color-change indicators show when the device is at the target.
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Smart Charting


A desk light is available for tabletop tasks like QC charting, balancing the patient experience while illuminating technologist tasks.



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Smart positioning in MLO (mediolateral oblique)


3Dimensions™ system includes MLO smart positioning, which moves the tube head +/- 15 degrees in the opposite direction in which the C-arm is positioned, to allow the technologist greater access to the breast for easier positioning and improved workflow.¹
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SmartCurve® Paddle


SmartCurve breast stabilization system: The SmartCurve system mirrors the shape of the breast for even compression and improved patient comfort compared to standard compression.¹
References: 1. Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00119 Rev 003 (2017).
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SmartCurve® breast stabilization system


The fear of pain stops many women from making regular breast screening a healthcare priority. Not only does this put them at risk of a cancer being missed or diagnosed at a more advanced stage, but it can also have a negative impact on patient volume¹ and satisfaction scores.²


The SmartCurve breast stabilization system is proven to reduce the pain and discomfort often associated with standard mammography compression.¹𝄒³


By mirroring the curvature of the breast, the SmartCurve system better distributes the compression force over the entire breast, while also reducing pinching at the chest wall. Using accompanying image processing algorithms, image quality is preserved without compromising on accuracy with all three paddle sizes to address most breast sizes: large, small, and mini.³
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Stowable Keyboard (Drawer)


The keyboard is stored in a retractable tray and can be comfortably assessed by pulling the tray, saving space on the acquisition workstation.
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Table Light – Under table and biopsy field work lights


Dimmable LED lighting illuminates the work area
with both diffuse light and task lighting focused on
the breast.
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Table Movement


The Horizon A tabel top extends and lowers, making it easier for patients to get on and off.
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Tilt Positioning


Introducing the only high-resolution 3D mammography platform that tilts +/-10º in all views. The Envision platform adapts to each patient contour and is designed for the ultimate positioning flexibility to yield consistent, high-quality imaging that optimizes tissue visualization. Tilt positioning is more likely to improve incremental tissue capture by an average of 1.3cm.¹*


Because in mammography, millimeters matter.


* The use of tilt positioning on the Envision™ mammography platform is more likely to capture more breast tissue by an average of 1.3cm than without tilt. P value = 0.003 is used for exploratory purposes only, is nominal, and is not based on any formal hypothesis.


References
1. Based on an internal survey of 58 Patients and 7 Technologists. Inspired Health, November 2023. Unpublished internal Hologic data on file.



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Time saving technology


Save an average of 1-hour per day of interpretation time¹⁻³ with 3DQuorum® SmartSlice technology.


References
1. Report: CSR-00116 2. Physician Labeling: MAN-06153 3. FDA approval number.P080003/S008
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Total and easy 360˚
breast access


Quickly access challenging lesions with a fully integrated C-arm that enables 360˚ breast access to accommodate a wide range of patients. Go from standard to lateral needle approach in seconds to accelerate procedures and ensure you can reach the lesions you are targeting.
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Touchscreen Controls


Intuitive touchscreen with straightforward icons and controls allowing the user to navigate through exams quickly and easily.
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Trendelenburg Positioning


Trendelenburg positioning for vasovagial reaction.
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TriMark®, CeleroMark™, SecurMark® and Tumark® markers


A Shape for Any Case. Hologic provides distinct marker shapes with options for great long-term ultrasound visibility. Designed so you can identify sites with confidence.


* Launching Early 2024
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TriMark®, CeleroMark™, SecurMark® and Tumark® markers


A Shape for Any Case.


*Launching Early 2024
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TriMark®, CeleroMark™, SecurMark® and Tumark® markers


A Shape for Any Case.
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TruNode™ Single-Use
Gamma Probe System


Single-Patient Use
Reduces risk of cross-contamination and surgical site infections in patients with a sterile, disposable solution, while eliminating drapes and reprocessing.
Audible & Visual Feedback
Three detection modes optimize sentinel node, parathyroid and tumour localization procedures. 10% energy resolution facilitating precise hotspot localization.
Simple Placement
Minimally invasive and ergonomic design which provides full control to the surgeons. The User Feedback Unit (UFU) can be clipped to any IV pole creating zero footprint in the OR.


Important Safety Information
The TruNode™ Gamma Prove system is intended to detect and quantify relative amounts of gamma radiation from Tc-99m and I-125 radionuclides in the body or tissues. The TruNode Gamma Probe System is not intended for use in the central nervous system. For detailed benefit and risk information, please consult the IFU.



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Tube Movement During Tomosynthesis


When selecting ClarityHD the tube moves over an angle of 15°. This allows for the faceshield to remain in place during the biopsy procedure.
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Tuflex™ Thread marker


Providing Flexible Scheduling.



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Tuloc™ localization wires


Easy Handling, precise localization of breast lesions.



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Tumark® Vision marker


A Shape for Any Case.
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References:
1. Jochelson M, Dershaw D, Sung J, et al., Bilateral contrast-enhanced dual-energy digital mammography: feasibility and comparison with conventional digital mammography and MR imaging in women with known breast carcinoma, Radiology 266(3) (2013) 743–75
2. Chou C, Lewin J, Chiang C et al. "Clinical Evaluation of Contrast-Enhanced Digital Mammography and Contrast Enhanced Tomosynthesis-Comparison to Contrast-Enhanced Breast MRI" Eur J Radiol. 2015 Dec; 84(12):2501-8. [Epub 2015 Oct 1]
3. Cozzi A, Magni V, Zanardo M, et al. Contrast-enhanced Mammography: A Systematic Review and Meta-Analysis of Diagnostic Performance. Radiology. 2022 Mar;302(3):568-581.
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References:
1. Internal testing performed at Hologic and maintained in PLM system: TRP_20011_054, Hologic Data on File.
2. Eviva® Stereotactic Guided Breast Biopsy System Handpiece Instructions for Use: AW-02708 (https://www.hologic.com/package-inserts/breast-skeletal-health-products/eviva-breast-biopsy-system-ifus)
3. Kaplan, S. 2010. The Benefits of the Hologic Eviva Vacuum-Assisted Stereotactic Breast Biopsy Device, WP-00023 (4/11).
4. Verification & design reports: VER-04202, VER-04111, VER-03205, VER-03792, DHM-02115, DHM-02203, Hologic Data on File.
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References:
1. MISC-03680. Sertera Limited Market Release (LMR) initial survey. 95% of physicians stated that the Sertera biopsy device was easy to arm & fire and allowed for one-handed operation. Data collected from 100 cases performed at various settings using the Sertera biopsy device. 2015. Hologic Data on file.
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References:
1.Englander, B. An Evaluation of the Hologic® Celero Vacuum Assisted Handheld Device for Ultrasound Guided Breast Biopsies. White Paper (WP-00006). 2013.
2. FDA Premarket Notification: K034021, 2004.
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EC Rep information where applicable.
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EC Rep information where applicable.
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Reference:
1. Schrading S, Martine D, Dirrichs T, et al. "Digital Breast Tomosynthesis-guided Vacuum-assisted Breast Biopsy: Initial Experiences and Comparison with Prone Stereotactic Vacuum-assisted Biopsy." Radiology. 2015 274:3, 654-662 E-pub 2014 Nov 12.
2. Smith A, Sumpkin J, Zuley M, et al. "Comparison of Prone Stereotactic vs. Upright Tomosynthesis Guided Vacuum Assisted Core Breast Biopsies." (paper presented at the annual meeting for the Radiological Society of North America. Chicago, II, November 2014).
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Reference:
1. Schrading S, Martine D, Dirrichs T, et al. "Digital Breast Tomosynthesis-guided Vacuum-assisted Breast Biopsy: Initial Experiences and Comparison with Prone Stereotactic Vacuum-assisted Biopsy." Radiology. 2015 274:3, 654-662 E-pub 2014 Nov 12.
2. Smith A, Sumpkin J, Zuley M, et al. "Comparison of Prone Stereotactic vs. Upright Tomosynthesis Guided Vacuum Assisted Core Breast Biopsies." (paper presented at the annual meeting for the Radiological Society of North America. Chicago, II, November 2014).
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Important Safety Information: The Hologic® Brevera® breast biopsy system with CorLumina® imaging technology is intended to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Brevera breast biopsy system excises targeted tissue and optionally delivers in-line radiographic images of the excised tissue. The Brevera breast biopsy system is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (for example, fibroadenoma, fibrocystic lesion), the Brevera breast biopsy system may also be used to partially remove such palpable lesions. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of histological abnormality, for example, malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedure. The Brevera breast biopsy system with CorLumina imaging technology is not intended for therapeutic applications. The Brevera breast biopsy system with CorLumina imaging technology is contraindicated for those patients who, based on the physician’s judgment, may be at increased risk or develop complications associated with core removal or biopsy. Patients receiving anticoagulant therapy or who may have bleeding disorders may be considered at increased risk of procedural complications. For detailed benefit and risk information, please consult the IFU.
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Important Safety Information
Faxitron Core is a cabinet digital x-ray imaging system indicated for use to generate and control x-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during percutaneous biopsy. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite. Please review the Instructions for Use for warnings and precautions pertaining to the use of this device.
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Image taken from Hologic R&D cases depicting 2D Contrast versus standard 2D and 3D™ image.
Copyright @ 2023 Hologic, Inc. Image on file at Hologic (03_IVIEW, 101_16)
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Image taken from Hologic R&D cases depicting MRI case on MultiView MultiModality software.
Copyright @ 2023 Hologic, Inc. Image on file at Hologic (MRN: 56342860)
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TERMS & CONDITIONS MISC-09311 REV001 Copyright 2025 Hologic, Inc. All rights reserved.
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