510(k) K112439 ยท LLZ System, Image Processing, Radiological
SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Oct 17, 2011 |
| Received | Aug 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112439
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2016 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx
Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image Terminated |
LLZ | None listed |
| May 10, 2016 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Synapse PACS software version 4.4.000,
Fujifilm Synapse PACS software version 4.4.001,
Fujifilm Synapse PACS software version 4.4.004,
Fujifilm Synapse PACS software version 4.4.010 and
Fujif Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.