510(k) K253800 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
0909FCE, 0909FCE-HS
| Applicant | Rayence Co., Ltd., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, Jul 31, 2026 |
| Received | Nov 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253800
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.