510(k) K051553 ยท LLZ System, Image Processing, Radiological
FUJI SYNAPSE WORKSTATION SOFTWARE
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Jul 7, 2005 |
| Received | Jun 13, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051553
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2006 | Fujifilm Medical System USA, Inc. Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.