510(k) K110186 ยท LLZ System, Image Processing, Radiological
SYNAPSE 3D LIVER ANALYSIS
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Apr 7, 2011 |
| Received | Jan 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110186
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.