510(k) K092238 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
| Applicant | Agfa Healthcare N.V., Mortsel, BE |
| Decision | Substantially Equivalent, Aug 11, 2009 |
| Received | Jul 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | AGFA Corp. Agfa Computed Radiography Systems with DX-G Digitizer.
DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physici Terminated |
MQB | None listed |
| Nov 26, 2010 | AGFA Corp. DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium. Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.