510(k) K121499 ยท IZF System, X-Ray, Tomographic
FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Nov 20, 2012 |
| Received | May 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121499
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.