510(k) K103465 ยท LLZ System, Image Processing, Radiological
SYNAPSE 3D CARDIAC TOOLS
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Jan 31, 2011 |
| Received | Nov 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103465
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.