510(k) K243376 ยท OWB Interventional Fluoroscopic X-Ray System
uAngio AVIVA CX
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Apr 28, 2025 |
| Received | Oct 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243376
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.