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510(k) K250692

GentleBeam (GB1000) by Voxel Ray Solutions, LLC — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2025
Date Received
March 7, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Therapeutic, X-Ray
Device Class
Class II
Regulation Number
892.5900
Review Panel
RA
Submission Type

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