510(k) K261932

Leksell® Vantage Stereotactic System by Elekta Solutions AB — Product Code HAW

K261932 is an FDA 510(k) premarket notification submitted by Elekta Solutions AB for the device "Leksell® Vantage Stereotactic System". The FDA issued a decision of Substantially Equivalent on August 5, 2026. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Elekta Solutions AB has at least 10 other 510(k) clearances on record.