510(k) K180809 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Eclipse II
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jun 21, 2018 |
| Received | Mar 28, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180809
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.