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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K261932
Device Name Leksell® Vantage Stereotactic System
Applicant
Elekta Solutions AB
Hagaplan 4
Stockholm,  SE 113 68
Applicant Contact Jesper Bruske
Correspondent
Elekta Solutions AB
Hagaplan 4
Stockholm,  SE 113 68
Correspondent Contact Jesper Bruske
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/09/2026
Decision Date 08/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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