510(k) K183474 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Carestream DRX-1 System with DRX Core Detectors
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jan 16, 2019 |
| Received | Dec 17, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183474
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.