510(k) K213520 ยท LLZ System, Image Processing, Radiological
AXIR-CX
| Applicant | Radisen Co., Ltd., Anyang-Si, KR |
| Decision | Substantially Equivalent, Aug 19, 2022 |
| Received | Nov 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213520
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.