Leksell® Vantage Stereotactic System— 510(k) K261932
Substantially EquivalentElekta Solutions AB
FDA 510(k) clearance K261932 for Leksell® Vantage Stereotactic System, Substantially Equivalent on 2026-08-05. Applicant: Elekta Solutions AB. Device class: 2.
Summary
Elekta Solutions' Leksell Vantage Stereotactic System is filed under product code HAW, neurological stereotaxic instruments. The record gives no model numbers.
Class II, 21 CFR 882.4560. Neurology is both the classification panel and the review panel, and it was a Traditional 510(k).
Elekta filed from Stockholm, Sweden. The decision came 57 calendar days after FDA received it (June 9 to August 5, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Elekta Solutions AB
- Product code
- Product code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Recent devices under product code HAW
view allMore clearances from Elekta Solutions AB
view allAdverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.