510(k) K122454 ยท KPR System, X-Ray, Stationary
FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Nov 20, 2012 |
| Received | Aug 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122454
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.