510(k) K161368 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
| Applicant | Agfa Healthcare N.V., Mortsel, BE |
| Decision | Substantially Equivalent, Sep 22, 2016 |
| Received | May 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161368
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.