Cios Spin
FDA 510(k) clearance K210054 · decided 2021-02-05
Clearance details
- K-number
- K210054
- Device name
- Cios Spin
- Applicant
- Siemens Medical Systems USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-01-08
- Decision date
- 2021-02-05
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designe recall (Z-0196-2024) | Siemens Medical Solutions USA, Inc | 2023-10-27 |