MUE

Death

5

Other

1

Total

6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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