510(k) K183245 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Carestream DRX-1 System with DRX Plus 2530 Detectors
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Feb 8, 2019 |
| Received | Nov 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183245
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.