510(k) K162287 ยท LLZ System, Image Processing, Radiological
Synapse 3D Perfusion Analysis
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Apr 6, 2017 |
| Received | Aug 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162287
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.