510(k) K111865 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Sep 30, 2011 |
| Received | Jun 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111865
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.