510(k) K192512 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Focus 35C Detector, Trimax 35C Detector
| Applicant | Iray Technology Taicang , Ltd., Taicang, CN |
| Decision | Substantially Equivalent, Oct 16, 2019 |
| Received | Sep 12, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192512
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.