510(k) K240094 ยท QIH Automated Radiological Image Processing Software
LumiNE US; Lumi
| Applicant | Augmedit B.V., Naarden, NL |
| Decision | Substantially Equivalent, Sep 10, 2024 |
| Received | Jan 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240094
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.