510(k) K250307 ยท ONO Neurosurgical Laser With Mr Thermography
Visualase V2 MRI-guided Laser Ablation System (9736422)
| Applicant | Medtronic Navigation, Lafayette CO, US |
| Decision | Substantially Equivalent, May 29, 2025 |
| Received | Feb 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250307
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.