| MAMMOMAT B.brilliant (11372950) (K253678) | Siemens Medical Solutions USA, Inc. | 2026-06-18 |
| Bellalun 2D (VDMS-1000S) (K254092) | Vieworks Co., Ltd. | 2026-05-28 |
| Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright (K260087) | GE Medical Systems SCS | 2026-03-24 |
| HESTIA (K243420) | Genoray Co., Ltd. | 2025-07-17 |
| 2430TCA with Xmaru W (K243849) | Rayence Co., Ltd. | 2025-03-12 |
| VIVIX-M (K241113) | Vieworks Co., Ltd. | 2025-01-16 |
| MAMMOMAT B.brilliant (K233539) | Siemens Medical Solutions USA, Inc. | 2024-03-27 |
| RMF-2000 (K220073) | DRTECH Corporation | 2023-01-26 |
| Planmed Clarity 2D, Planmed Clarify S (K211720) | Planmed OY | 2022-07-18 |
| Aspire Cristalle (K212873) | Fujifilm Corporation | 2022-05-27 |
| Digimamo D (K210151) | Vmi Tecnologias Ltda | 2022-03-01 |
| Helianthus (K202822) | Metaltronica Spa | 2021-12-15 |
| Senographe Pristina (K211725) | GE Healthcare | 2021-08-06 |
| SenoBright HD (K211215) | GE Healthcare | 2021-06-22 |
| 2430MCA with Xmaru W (K202902) | Rayence Co., Ltd. | 2021-06-21 |
| Planmed Clarity 2D and Clarity S (K192317) | Planmed OY | 2020-10-23 |
| Giotto Class (Models - 3000X-YY and 4000X-YY) (K200424) | Ims Giotto S.P.A. | 2020-06-18 |
| MAMMOMAT Revelation (K193166) | Siemens Medical Solutions USA, Inc. | 2020-06-12 |
| Pristina Serena Bright (K193334) | GE Healthcare | 2020-05-15 |
| Sample Imaging for Senographe Pristina (K190809) | GE Healthcare | 2019-07-29 |
| Pristina Serena 3D (K182951) | GE Healthcare | 2019-01-18 |
| Pristina Serena (K173576) | GE Healthcare | 2018-05-14 |
| Mammomat Revelation (K173408) | Siemens Medi Cal Solutions, Inc. | 2018-03-21 |
| Planmed Clarity (K163328) | Planmed OY | 2017-12-28 |
| SenoBright HD (K172404) | GE Healthcare | 2017-10-30 |
| ASPIRE Cristalle (K173132) | Fujifilm Medical Systems U.S.A, Inc. | 2017-10-27 |
| Adani MammoScan (K172027) | Adani | 2017-10-20 |
| Senographe Pristina (K163302) | GE Healthcare | 2017-09-01 |
| RSM 2430C (K170930) | DRTECH Corporation | 2017-04-27 |
| RSM 1824C with RConsole1 (K162670) | DRTECH Corporation | 2017-02-23 |
| Mammomat Fusion with Stereotactic Biopsy (K163252) | Siemens Medical Solutions USA, Inc. | 2017-01-10 |
| Senographe Pristina (K162268) | GE Healthcare | 2016-11-03 |
| MAMMOMAT Fusion (K151645) | Siemens Medical Solutions USA, Inc. | 2015-09-14 |
| ASPIRE CRISTALLE (K133972) | Fujifilm Medical Systems U.S.A, Inc. | 2014-03-25 |
| MICRODOSE SI (K130704) | Philips Digital Mammography Sweden AB | 2013-12-13 |
| SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) (K131885) | GE Medical Systems SCS | 2013-09-26 |
| MAMMOMAT INSPIRATION PRIME (K123520) | Siemens Medical Solutions USA, Inc. | 2013-06-11 |
| ICRCO 3600M (K122510) | Icrco, Inc. | 2013-04-26 |
| MAMMOMAL INSPIRATION (K122286) | Siemens Medical Solutions USA, Inc. | 2013-02-22 |
| MICRODOSE SI (K123995) | Philips Digital Mammography Sweden AB | 2013-02-01 |
| CONTRAST ENHANCED DIGITAL MAMMOGRAPHY (K123873) | Hologic, Inc. | 2013-01-29 |
| PLANMED NUANCE DIGIGUIDE (K121963) | Planmed OY | 2012-11-21 |
| ASPIRE HD PLUS, ASPIRE HD-S (K121674) | Fujifilm Medical System U.S.A., Inc. | 2012-09-21 |
| KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) (K120246) | Carestream Health, Inc. | 2012-08-28 |
| PHILIPS MICRODOSE (K120255) | Philips Digital Mammography Sweden AB | 2012-04-19 |
| KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM (K110717) | Konica Minolta Medical & Graphic, Inc. | 2011-12-23 |
| SENOGRAPHE DS, SENOGRAPHE ESSENTIAL (K110798) | General Electric Company | 2011-12-22 |
| CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER (K111324) | Agfa Healthcare N.V. | 2011-12-22 |
| ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR (K111646) | Fujifilm Medical System U.S.A., Inc. | 2011-12-08 |
| GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L (K111434) | Giotto USA, LLC | 2011-10-27 |
| SENOGRAPH DS, SENOGRAPH ESSENSTIAL (K103485) | General Electric Company | 2011-10-06 |
| MAMMODIAGNOST DR (K110572) | Philips Medical Systems | 2011-09-23 |
| PLANMED NUANCE EXCEL (K111361) | Planmeca USA, Inc. | 2011-09-23 |
| ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM (K110729) | Fujifilm Medical Systems U.S.A, Inc. | 2011-09-01 |
| SECTRA MICRODOSE MAMMOGRAPHY (K110025) | Sectra Imtec AB | 2011-04-28 |