510(k) K130542 ยท LLZ System, Image Processing, Radiological
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Jun 14, 2013 |
| Received | Mar 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130542
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.