510(k) K251532 ยท LLZ System, Image Processing, Radiological
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
| Applicant | Mighty Oak Medical, Englewood CO, US |
| Decision | Substantially Equivalent, Nov 3, 2025 |
| Received | May 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251532
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.