510(k) K253077 ยท QIH Automated Radiological Image Processing Software
uOmnispace.MR
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Apr 22, 2026 |
| Received | Sep 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253077
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.