MAMMOMAL INSPIRATION
FDA 510(k) clearance K122286 · decided 2013-02-22
Clearance details
- K-number
- K122286
- Device name
- MAMMOMAL INSPIRATION
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-30
- Decision date
- 2013-02-22
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- MUE
- Device class
- 2
- Regulation number
- 892.1715
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mavern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and s recall (Z-0523-2015) | Siemens Medical Solutions USA, Inc | 2014-12-06 |
| Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is inten recall (Z-0086-2015) | Siemens Medical Solutions USA, Inc | 2014-10-17 |
| MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotact recall (Z-1638-2014) | Siemens Medical Solutions USA, Inc | 2014-05-20 |
| Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography recall (Z-1694-2013) | Siemens Medical Solutions USA, Inc | 2013-07-11 |
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 |