510(k) K153464 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
FDR D-EVO flat Panel Detector System
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Apr 8, 2016 |
| Received | Dec 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153464
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.