510(k) K090672 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
| Applicant | Agfa Healthcare N.V., Mortsel, BE |
| Decision | Substantially Equivalent, May 18, 2009 |
| Received | Mar 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090672
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2016 | AGFA Healthcare Corp. Agfa Healthcare NX 3.0.8950 Imaging Processing Software Terminated |
MQB | None listed |
| Sep 2, 2009 | AGFA Corp. NX 2008 Central Monitoring System (CMS). Product code: E2FB6
Agfa's Computed Radiography Systems with NX Workstations are intended for use in
providing diagnostic quality images to aid the physicia Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.