510(k) K111945 ยท LLZ System, Image Processing, Radiological
IMPAX NEXT GENERATION
| Applicant | Agfa Healthcare N.V., Mortsel, BE |
| Decision | Substantially Equivalent, Aug 5, 2011 |
| Received | Jul 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111945
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2018 | Agfa Healthcare NV Enterprise Imaging Desktops
Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for Terminated |
LLZ | None listed |
| Feb 3, 2014 | AGFA Corp. IMPAX RIS QDOC 5.8 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.