510(k) K254015 ยท QIH Automated Radiological Image Processing Software
CoLumbo C-Spine
| Applicant | Smart Soft Healthcare AD, Varna, BG |
| Decision | Substantially Equivalent, Apr 1, 2026 |
| Received | Dec 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254015
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.