K210054 is an FDA 510(k) clearance for the Cios Spin. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Siemens Medical Systems USA, Inc. (Malvern, US). The FDA issued a Cleared decision on February 5, 2021, 28 days after receiving the submission on January 8, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K210054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2021 |
| Decision Date | February 05, 2021 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB - Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |