510(k) K254013 ยท LLZ System, Image Processing, Radiological
SubtleHD-PET (1.x)
| Applicant | Subtle Medical, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, May 14, 2026 |
| Received | Dec 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254013
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.