510(k) K250369 ยท QIH Automated Radiological Image Processing Software
Axial3D Insight
| Applicant | Axial Medical Printing Limited, Belfast, GB |
| Decision | Substantially Equivalent, Sep 18, 2025 |
| Received | Feb 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250369
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.