SOMATOM DEFINITION FLASH
FDA 510(k) clearance K121072 · decided 2012-05-08
Clearance details
- K-number
- K121072
- Device name
- SOMATOM DEFINITION FLASH
- Applicant
- Siemens Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-09
- Decision date
- 2012-05-08
- Days to decision
- 29 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 |
|---|---|---|
| Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model recall (Z-3025-2020) | Siemens Medical Solutions USA, Inc | 2020-09-28 |
| SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS recall (Z-0605-2017) | Siemens Medical Solutions USA, Inc | 2016-11-17 |
| Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. recall (Z-1520-2016) | Siemens Medical Solutions USA, Inc | 2016-04-19 |