510(k) K242515 ยท IZL System, X-Ray, Mobile
uDR 380i Pro
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Oct 10, 2024 |
| Received | Aug 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242515
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.