510(k) K250330 ยท QIH Automated Radiological Image Processing Software
3mensio Workstation
| Applicant | Pie Medical Imaging BV, Maastricht, NL |
| Decision | Substantially Equivalent, Nov 3, 2025 |
| Received | Feb 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250330
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2026 | PIE Medical Imaging B.V. 3mensio Workstation (Vascular Fenestrated) software Open, Classified |
QIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.