510(k) K253446 ยท KPR System, X-Ray, Stationary
AeroDR TX c02
| Applicant | Dk Medical Systems Co., Ltd., Pyeongtaek-Si, KR |
| Decision | Substantially Equivalent, Apr 10, 2026 |
| Received | Oct 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253446
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.