510(k) K151859 ยท LLZ System, Image Processing, Radiological
Synapse Cardiovascular
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Aug 12, 2015 |
| Received | Jul 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151859
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2024 | FUJIFILM Healthcare Americas Corporation Synapse CV 6. with AR.
A web-based application as the primary user interface for the processing of medical images. Open, Classified |
LLZ | None listed |
| Apr 30, 2021 | Fujifilm Medical Systems U.S.A., Inc. Synapse Cardiovascular (Synapse CV).
Software Versions: 6.0 to 6.2.1
The Synapse Cardiovascular image is a management and reporting system Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.