510(k) K160579 ยท LLZ System, Image Processing, Radiological
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
| Applicant | Rayence Co., Ltd., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, Apr 8, 2016 |
| Received | Mar 1, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160579
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.