510(k) K213645 ยท QIH Automated Radiological Image Processing Software
ClearPoint Maestro Brain Model
| Applicant | ClearPoint Neuro, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 8, 2022 |
| Received | Nov 18, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213645
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.