510(k) K142647 ยท LLZ System, Image Processing, Radiological
mint Lesion
| Applicant | Mint Medical GmbH, Dossenheim, DE |
| Decision | Substantially Equivalent, Apr 13, 2015 |
| Received | Sep 17, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142647
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2026 | Mint Medical GmbH Mint Lesion;
Software Versions: 3.4.0 up to 3.9.5.; Open, Classified |
LLZ | None listed |
| Dec 20, 2024 | Mint Medical GmbH mint Lesion, Software Versions: 3.9.0 through 3.9.5. Open, Classified |
LLZ | None listed |
| Dec 20, 2024 | Mint Medical GmbH mint Lesion, Software Versions: 3.10.0 and 3.10.1. Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.