SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16
FDA 510(k) clearance K133424 · decided 2014-01-17
Clearance details
- K-number
- K133424
- Device name
- SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-08
- Decision date
- 2014-01-17
- Days to decision
- 70 days
- Clearance type
- Special
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- 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 |
|---|---|---|
| SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction recall (Z-1933-2015) | Siemens Medical Solutions USA, Inc | 2015-06-27 |
| SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction o recall (Z-1934-2015) | Siemens Medical Solutions USA, Inc | 2015-06-27 |
| SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional i recall (Z-1644-2015) | Siemens Medical Solutions USA, Inc | 2015-05-22 |
| SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional recall (Z-1645-2015) | Siemens Medical Solutions USA, Inc | 2015-05-22 |
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 |