510(k) K254120 ยท QIH Automated Radiological Image Processing Software
SubtleHD-CT (1.x)
| Applicant | Subtle Medical, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Dec 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254120
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.