510(k) K190866 ยท LLZ System, Image Processing, Radiological
XmaruView V1 (Xmaru Chiroview, Xmaru Podview)
| Applicant | Rayence Co., Ltd., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, Apr 30, 2019 |
| Received | Apr 3, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190866
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.