510(k) K192630 ยท LLZ System, Image Processing, Radiological
uWS-MI
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Jun 11, 2020 |
| Received | Sep 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192630
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.