510(k) K262442 ยท LLZ System, Image Processing, Radiological
HipStudio Analysis
| Applicant | Replasia BV, Leuven, BE |
| Decision | Substantially Equivalent, Sep 22, 2026 |
| Received | Jul 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262442
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.