510(k) K261932 · HAW Neurological Stereotaxic Instrument
Leksell® Vantage Stereotactic System
| Applicant | Elekta Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Aug 5, 2026 |
| Received | Jun 9, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261932
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.