Full Field Digital, System, X-Ray, Mammographic
Regulation 892.1715
4510(k)s in 12 months (56 all time)
5recalls in 12 months (41 all time)
22recalls that name a 510(k)
Top companies in MUE
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 7 | 12 |
| GE Healthcare | 9 | 9 |
| Fujifilm Medical Systems U.S.A, Inc. | 3 | 8 |
| Hologic, Inc. | 2 | 5 |
| Planmed OY | 4 | 0 |
| DRTECH Corporation | 3 | 0 |
| Fujifilm Medical System U.S.A., Inc. | 2 | 1 |
| GE Medical Systems SCS | 2 | 1 |
| Philips Digital Mammography Sweden AB | 3 | 0 |
| Fischer Imaging Corporation | 0 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2026 | K254090 | I-View® Hologic, Inc. | MUE |
| Jun 18, 2026 | K253678 | MAMMOMAT B.brilliant (11372950) Siemens Medical Solutions USA, Inc. | MUE |
| May 28, 2026 | K254092 | Bellalun 2D (VDMS-1000S) Vieworks Co., Ltd., KR | MUE |
| Mar 24, 2026 | K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright GE Medical Systems SCS, FR | MUE |
| Jul 17, 2025 | K243420 | HESTIA Genoray Co., Ltd., KR | MUE |
| Mar 12, 2025 | K243849 | 2430TCA with Xmaru W Rayence Co., Ltd., KR | MUE |
| Jan 16, 2025 | K241113 | VIVIX-M Vieworks Co., Ltd., KR | MUE |
| Mar 27, 2024 | K233539 | MAMMOMAT B.brilliant Siemens Medical Solutions USA, Inc. | MUE |
| Jan 26, 2023 | K220073 | RMF-2000 DRTECH Corporation, KR | MUE |
| Jul 18, 2022 | K211720 | Planmed Clarity 2D, Planmed Clarify S Planmed OY, FI | MUE |
| May 27, 2022 | K212873 | Aspire Cristalle Fujifilm Corporation, JP | MUE |
| Mar 1, 2022 | K210151 | Digimamo D Vmi Tecnologias Ltda, BR | MUE |
| Dec 15, 2021 | K202822 | Helianthus Metaltronica Spa, IT | MUE |
| Aug 6, 2021 | K211725 | Senographe Pristina GE Healthcare, FR | MUE |
| Jun 22, 2021 | K211215 | SenoBright HD GE Healthcare, FR | MUE |
| Jun 21, 2021 | K202902 | 2430MCA with Xmaru W Rayence Co., Ltd., KR | MUE |
| Oct 23, 2020 | K192317 | Planmed Clarity 2D and Clarity S Planmed OY, FI | MUE |
| Jun 18, 2020 | K200424 | Giotto Class (Models - 3000X-YY and 4000X-YY) Ims Giotto S.P.A., IT | MUE |
| Jun 12, 2020 | K193166 | MAMMOMAT Revelation Siemens Medical Solutions USA, Inc. | MUE |
| May 15, 2020 | K193334 | Pristina Serena Bright GE Healthcare, FR | MUE |
| Jul 29, 2019 | K190809 | Sample Imaging for Senographe Pristina GE Healthcare, FR | MUE |
| Jan 18, 2019 | K182951 | Pristina Serena 3D GE Healthcare, FR | MUE |
| May 14, 2018 | K173576 | Pristina Serena GE Healthcare, FR | MUE |
| Mar 21, 2018 | K173408 | Mammomat Revelation Siemens Medi Cal Solutions, Inc. | MUE |
| Dec 28, 2017 | K163328 | Planmed Clarity Planmed OY, FI | MUE |
| Oct 30, 2017 | K172404 | SenoBright HD GE Healthcare, FR | MUE |
| Oct 27, 2017 | K173132 | ASPIRE Cristalle Fujifilm Medical Systems U.S.A, Inc. | MUE |
| Oct 20, 2017 | K172027 | Adani MammoScan Adani, BY | MUE |
| Sep 1, 2017 | K163302 | Senographe Pristina GE Healthcare, FR | MUE |
| Apr 27, 2017 | K170930 | RSM 2430C DRTECH Corporation, KR | MUE |
| Feb 23, 2017 | K162670 | RSM 1824C with RConsole1 DRTECH Corporation, KR | MUE |
| Jan 10, 2017 | K163252 | Mammomat Fusion with Stereotactic Biopsy Siemens Medical Solutions USA, Inc. | MUE |
| Nov 3, 2016 | K162268 | Senographe Pristina GE Healthcare, FR | MUE |
| Sep 14, 2015 | K151645 | MAMMOMAT Fusion Siemens Medical Solutions USA, Inc. | MUE |
| Mar 25, 2014 | K133972 | ASPIRE CRISTALLE Fujifilm Medical Systems U.S.A, Inc. | MUE |
| Dec 13, 2013 | K130704 | MICRODOSE SI Philips Digital Mammography Sweden AB, SE | MUE |
| Sep 26, 2013 | K131885 | SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) GE Medical Systems SCS, FR | MUE |
| Jun 11, 2013 | K123520 | MAMMOMAT INSPIRATION PRIME Siemens Medical Solutions USA, Inc. | MUE |
| Apr 26, 2013 | K122510 | ICRCO 3600M Icrco, Inc. | MUE |
| Feb 22, 2013 | K122286 | MAMMOMAL INSPIRATION Siemens Medical Solutions USA, Inc. | MUE |
| Feb 1, 2013 | K123995 | MICRODOSE SI Philips Digital Mammography Sweden AB, SE | MUE |
| Jan 29, 2013 | K123873 | CONTRAST ENHANCED DIGITAL MAMMOGRAPHY Hologic, Inc. | MUE |
| Nov 21, 2012 | K121963 | PLANMED NUANCE DIGIGUIDE Planmed OY, FI | MUE |
| Sep 21, 2012 | K121674 | ASPIRE HD PLUS, ASPIRE HD-S Fujifilm Medical System U.S.A., Inc. | MUE |
| Aug 28, 2012 | K120246 | KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) Carestream Health, Inc. | MUE |
| Apr 19, 2012 | K120255 | PHILIPS MICRODOSE Philips Digital Mammography Sweden AB, SE | MUE |
| Dec 23, 2011 | K110717 | KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM Konica Minolta Medical & Graphic, Inc. | MUE |
| Dec 22, 2011 | K111324 | CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER Agfa Healthcare N.V. | MUE |
| Dec 22, 2011 | K110798 | SENOGRAPHE DS, SENOGRAPHE ESSENTIAL General Electric Company | MUE |
| Dec 8, 2011 | K111646 | ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR Fujifilm Medical System U.S.A., Inc. | MUE |
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