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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K250692
Device Name GentleBeam (GB1000)
Applicant
Voxel Ray Solutions, LLC
200 Frontage Rd.
Suite 200
Burr Ridge,  IL  60527
Applicant Contact Nicolas Soro
Correspondent
Voxel Ray Solutions, LLC
200 Frontage Rd.
Suite 200
Burr Ridge,  IL  60527
Correspondent Contact Nicolas Soro
Regulation Number892.5900
Classification Product Code
JAD  
Date Received03/07/2025
Decision Date 12/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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