510(k) K180989 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
PEDRA-17F Digital Flat Panel X-ray Detector
| Applicant | Radisen, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Jun 13, 2018 |
| Received | Apr 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180989
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.