510(k) K183144 ยท OWB Interventional Fluoroscopic X-Ray System
uMC 560i
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Dec 19, 2019 |
| Received | Nov 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183144
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.