510(k) K080945 ยท IZL System, X-Ray, Mobile
FCR GO PORTABLE DIGITAL X-RAY SYSTEM
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Apr 18, 2008 |
| Received | Apr 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080945
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.