510(k) K243005 ยท QIH Automated Radiological Image Processing Software
AudaxCeph Cephalogram Analysis Software
| Applicant | Audax D.O.O., Ljubljana, SI |
| Decision | Substantially Equivalent, May 30, 2025 |
| Received | Sep 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243005
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.