K250692
- 510(k) number
- K250692
- Device name
- GentleBeam (GB1000)
- Applicant
- Voxel Ray Solutions, LLC IL · US
- Product code
- JAD — System, Therapeutic, X-Ray
- Decision date
- 2025-12-03
- Date received
- 2025-03-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K250692.pdf
Official FDA record: K250692
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.