510(k) K253185 ยท IZL System, X-Ray, Mobile
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
| Applicant | Carestream Health, Rochester NY, US |
| Decision | Substantially Equivalent, Mar 11, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253185
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.