510(k) K160108 ยท LLZ System, Image Processing, Radiological
Synapse PACS
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Feb 3, 2016 |
| Received | Jan 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160108
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2025 | FUJIFILM Healthcare Americas Corporation Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200. Open, Classified |
LLZ | None listed |
| Mar 2, 2021 | Fujifilm Medical Systems U.S.A., Inc. Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with Open, Classified |
LLZ | None listed |
| Sep 11, 2020 | Fujifilm Medical Systems U.S.A., Inc. Synapse PACS Software Versions 5.1 and higher Open, Classified |
LLZ | None listed |
| May 22, 2020 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server) Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.