GentleBeam (GB1000)— 510(k) K250692
Substantially EquivalentVoxel Ray Solutions, LLC
FDA 510(k) clearance K250692 for GentleBeam (GB1000), Substantially Equivalent on 2025-12-03. Applicant: Voxel Ray Solutions, LLC. Device class: 2.
Clearance details
- Applicant
- Voxel Ray Solutions, LLC
- Product code
- Code JAD
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burr Ridge, IL, US
Recent devices under product code JAD
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