510(k) K040555 ยท LLZ System, Image Processing, Radiological
IMPAX CLIENT EMBRACE
| Applicant | Agfa Corp., Waterloo, Ontario, CA |
| Decision | Substantially Equivalent, May 26, 2004 |
| Received | Mar 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2008 | AGFA Corp. IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiving and Communications systems (PACs), used in the acceptance, transfer, display, storage and digital pr Terminated |
LLZ | None listed |
| Sep 11, 2008 | AGFA Corp. IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images. Terminated |
LLZ | None listed |
| Sep 11, 2008 | AGFA Corp. WEB1000 Versions 3.1, 4.1 and 5.1, Picture Archiving and Communications systems (PACs), used in the acceptance, transfer, display, storage and digital processing of medical images. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.