510(k) K130383 ยท LLZ System, Image Processing, Radiological
SYNAPSE 3D CARDIAC TOOLS
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Apr 9, 2013 |
| Received | Feb 14, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130383
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.