510(k) K121948 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
CR 10-X DIGITIZER
| Applicant | Agfa Healthcare N.V., Mortsel, BE |
| Decision | Substantially Equivalent, Jul 20, 2012 |
| Received | Jul 3, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121948
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2013 | AGFA Corp. CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the im Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.