510(k) K152138 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
FDR D-EVO GL Flat Panel Detector System
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Nov 5, 2015 |
| Received | Jul 31, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152138
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.