510(k) K071297 ยท LLZ System, Image Processing, Radiological
IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)
| Applicant | Agfa Healthcare Corp., Greenville SC, US |
| Decision | Substantially Equivalent, Jun 22, 2007 |
| Received | May 9, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2013 | AGFA Corp. IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS). Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.