510(k) K243556 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
| Applicant | Iray Imaging Technology (Haining) Limited, Haining, CN |
| Decision | Substantially Equivalent, Mar 18, 2025 |
| Received | Nov 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243556
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.