K250954 is an FDA 510(k) clearance for the DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Carestream Health (Rochester, US). The FDA issued a Cleared decision on January 20, 2026, 298 days after receiving the submission on March 28, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K250954 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2025 |
| Decision Date | January 20, 2026 |
| Days to Decision | 298 days |
| Submission Type | Traditional |
| 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 |