Cleared Traditional

GentleBeam (GB1000)

K250692 · Voxel Ray Solutions, LLC · Radiology

Dec 2025

Decision

271d

Days

Class 2

Risk

About This 510(k) Submission

K250692 is an FDA 510(k) clearance for the GentleBeam (GB1000), a System, Therapeutic, X-ray (Class II — Special Controls, product code JAD), submitted by Voxel Ray Solutions, LLC (Burr Ridge, US). The FDA issued a Cleared decision on December 3, 2025, 271 days after receiving the submission on March 7, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5900.

Submission Details

510(k) Number	K250692 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 2025
Decision Date	December 03, 2025
Days to Decision	271 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF