510(k) K253944 ยท QIH Automated Radiological Image Processing Software
Data Analysis Facilitation Suite (DAFS)
| Applicant | Voronoi Health Analytics Incorporated, Vancouver, CA |
| Decision | Substantially Equivalent, Mar 16, 2026 |
| Received | Dec 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253944
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.