510(k) K243250 ยท QIH Automated Radiological Image Processing Software
SubtleHD (1.x)
| Applicant | Subtle Medical, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Feb 12, 2025 |
| Received | Oct 15, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243250
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.