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 |
|---|---|---|---|
| Oct 27, 2011 | K111434 | GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L Giotto USA, LLC | MUE |
| Oct 6, 2011 | K103485 | SENOGRAPH DS, SENOGRAPH ESSENSTIAL General Electric Company | MUE |
| Sep 23, 2011 | K111361 | PLANMED NUANCE EXCEL Planmeca USA, Inc. | MUE |
| Sep 23, 2011 | K110572 | MAMMODIAGNOST DR Philips Medical Systems | MUE |
| Sep 1, 2011 | K110729 | ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM Fujifilm Medical Systems U.S.A, Inc. | MUE |
| Apr 28, 2011 | K110025 | SECTRA MICRODOSE MAMMOGRAPHY Sectra Imtec AB, SE | MUE |
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