510(k) K200973 ยท LLZ System, Image Processing, Radiological
Synapse 3D Cardiac Tools
| Applicant | Fujifilm Corporaton, Tokyo, JP |
| Decision | Substantially Equivalent, Aug 27, 2020 |
| Received | Apr 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200973
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.