K223842 is an FDA 510(k) clearance for the DRX - Compass. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Carestream Health, Inc. (China (Shanghai) Pilot Free Trade Zone, CN). The FDA issued a Cleared decision on January 20, 2023, 29 days after receiving the submission on December 22, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K223842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2022 |
| Decision Date | January 20, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |