510(k) K153736 ยท LLZ System, Image Processing, Radiological
3mensio Workstation
| Applicant | Pie Medical Imaging BV, Maastricht, NL |
| Decision | Substantially Equivalent, May 27, 2016 |
| Received | Dec 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153736
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2025 | PIE Medical Imaging B.V. 3mensio Workstation (Vascular Fenestrated) software Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.