Data / Medical devices / United States / Voxel Ray Solutions, LLC
Voxel Ray Solutions, LLC: FDA-registered device maker in Burr Ridge, IL, United States, 1 510(k) clearance
Voxel Ray Solutions, LLC is registered with the FDA (registration 3036107971) in Burr Ridge, IL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 3, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036107971
- Address
- 200 S Frontage Rd Ste 200, Burr Ridge, IL, United States, 60527
- Owner or operator
- Voxel Ray Solutions, LLC (10092818)
- Roles
- Specification developer
- First device listed
- December 10, 2025
- Registered through
- 2026
- Brand names listed
- GentleBeam
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Therapeutic, X-Ray | JAD | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 3, 2025 | K250692 | GentleBeam (GB1000) | JAD | Substantially Equivalent | Voxel Ray Solutions, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.