510(k) K133782 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
NOVA FA DR SYSTEM
| Applicant | Sedecal., Sa., Naples FL, US |
| Decision | Substantially Equivalent, Mar 21, 2014 |
| Received | Dec 12, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133782
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2018 | Sedecal S.A. Sedecal NOVA FA DR System. for diagnostic radiography. Open, Classified |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.