510(k) K213646 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Focus HD 35 Detector
| Applicant | Iray Technology Taicang , Ltd., Taicang, CN |
| Decision | Substantially Equivalent, Mar 29, 2022 |
| Received | Nov 4, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213646
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.