MAMMOMAT Revelation
FDA 510(k) clearance K193166 · decided 2020-06-12
Clearance details
- K-number
- K193166
- Device name
- MAMMOMAT Revelation
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-11-15
- Decision date
- 2020-06-12
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- MUE
- Device class
- 2
- Regulation number
- 892.1715
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| MAMMOMAT B.brilliant (11372950) (K253678) | Siemens Medical Solutions USA, Inc. | 2026-06-18 |
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| MAMMOMAT B.brilliant (K233539) | Siemens Medical Solutions USA, Inc. | 2024-03-27 |
| RMF-2000 (K220073) | DRTECH Corporation | 2023-01-26 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MAMMOMAT Revelation; recall (Z-0877-2026) | Siemens Medical Solutions USA, Inc | 2025-12-03 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008) | Siemens Medical Solutions USA, Inc. | 2024-09-23 |
| MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007) | Siemens Medical Solutions USA, Inc. | 2020-08-21 |
| MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006) | Siemens Medical Solutions USA, Inc. | 2019-12-10 |
| Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005) | Siemens Medical Solutions USA, Inc. | 2017-09-29 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003) | Siemens Medical Solutions USA, Inc. | 2017-03-23 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001) | Siemens Medical Solutions USA, Inc. | 2016-05-12 |
| MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002) | Siemens Medical Solutions USA, Inc. | 2016-01-13 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011) | Siemens Medical Solutions USA, Inc. | 2015-04-21 |