Cios Alpha
FDA 510(k) clearance K181560 · decided 2018-10-24
Clearance details
- K-number
- K181560
- Device name
- Cios Alpha
- Applicant
- Siemens Medical Systems USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-14
- Decision date
- 2018-10-24
- Days to decision
- 132 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - recall (Z-2848-2020) | Siemens Medical Solutions USA, Inc | 2020-08-22 |
| Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Sp recall (Z-1957-2020) | Siemens Medical Solutions USA, Inc | 2020-05-04 |
| Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios S recall (Z-1958-2020) | Siemens Medical Solutions USA, Inc | 2020-05-04 |
| Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA recall (Z-2127-2020) | Siemens Medical Solutions USA, Inc | 2020-05-04 |