510(k) K250954 ยท KPR System, X-Ray, Stationary
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
| Applicant | Carestream Health, Rochester NY, US |
| Decision | Substantially Equivalent, Jan 20, 2026 |
| Received | Mar 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250954
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.