K212442 is an FDA 510(k) clearance for the Cydar EV (Series B) and Cydar EV Maps. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Cydar , Ltd. (Barrington, GB). The FDA issued a Cleared decision on December 3, 2021, 121 days after receiving the submission on August 4, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K212442 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2021 |
| Decision Date | December 03, 2021 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| 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 |