K213691 is an FDA 510(k) clearance for the Solas OR. This device is classified as a Cabinet, X-ray System (Class II - Special Controls, product code MWP).
Submitted by Cirdan Imaging, Ltd. (Lisburn, GB). The FDA issued a Cleared decision on December 22, 2021, 29 days after receiving the submission on November 23, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K213691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2021 |
| Decision Date | December 22, 2021 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MWP - Cabinet, X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |