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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K250692

510(k) cleared

GentleBeam (GB1000)

Voxel Ray Solutions, LLC · Dec 3, 2025 · K250692

FDA cleared the GentleBeam (GB1000) from Voxel Ray Solutions, LLC on Dec 3, 2025 under K250692, a traditional 510(k). The device falls under product code JAD, System, Therapeutic, X-Ray, regulated at 21 CFR 892.5900 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 7, 2025. The decision came 271 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Voxel Ray Solutions, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250692?

K250692 is the FDA 510(k) for GentleBeam (GB1000), submitted by Voxel Ray Solutions, LLC. FDA's decision date was Dec 3, 2025, under product code JAD (System, Therapeutic, X-Ray).

Who makes the GentleBeam (GB1000)?

Voxel Ray Solutions, LLC, based in Burr Ridge, IL, is the applicant of record for K250692.

How long did the K250692 review take?

FDA received the submission on Mar 7, 2025 and issued its decision on Dec 3, 2025, 271 days later.

← All decisions in December 2025