K261932
- 510(k) number
- K261932
- Device name
- Leksell® Vantage Stereotactic System
- Applicant
- Elekta Solutions AB SE
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2026-08-05
- Date received
- 2026-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K261932.pdf
Official FDA record: K261932
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.