510(k) K092669 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
DX-D IMAGING PACKAGE
| Applicant | Agfa Healthcare N.V., Mortsel, BE |
| Decision | Substantially Equivalent, Nov 6, 2009 |
| Received | Aug 31, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092669
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 19, 2012 | AGFA Corp. Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems)
Product Usage:
DX-D Imagin Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.