510(k) K260116 ยท LLZ System, Image Processing, Radiological
CustoMED Viewer
| Applicant | CustoMED , Ltd., Ramat Gan, IL |
| Decision | Substantially Equivalent, Jun 3, 2026 |
| Received | Jan 14, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260116
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.