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510(k) K250692

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

K250692 is an FDA 510(k) premarket notification submitted by Voxel Ray Solutions, LLC for the device "GentleBeam (GB1000)". The FDA issued a decision of Substantially Equivalent on December 3, 2025. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900.

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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  • K213942 — Esteya (January 11, 2022)
  • K190255 — Sensus Healthcare TVM Balloon Applicator (February 21, 2019)
  • K182641 — Sensus IORT System (February 21, 2019)
  • K173425 — SRT-100+ (March 23, 2018)
  • K172080 — Photoelectric Therapy System (September 29, 2017)
  • K162568 — INTRABEAM 600 (December 15, 2016)
  • K153570 — Axxent Electronic Brachytherapy System Model 110 XP 1200 (February 25, 2016)
  • K150037 — Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Ima (October 16, 2015)

FDA data resources