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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
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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