Data / Medical devices / Canada / Voxneuro, Inc.
Voxneuro, Inc.: FDA-registered device maker in Toronto Ontario, Canada, 1 510(k) clearance
Voxneuro, Inc. is registered with the FDA (registration 3016851752) in Toronto Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 12, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016851752
- Address
- 121 King St W Suite 2150, Toronto Ontario, Canada, M5H 3T9
- Owner or operator
- VoxNeuro, Inc. (10081696)
- Roles
- Manufacturer
- First device listed
- June 16, 2026
- Registered through
- 2027
- Brand names listed
- Cognitive Function Neuroimaging (cfNI) Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Normalizing Quantitative Electroencephalograph Software | OLU | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 12, 2026 | K253015 | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | OLU | Substantially Equivalent | VoxNeuro, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 12, 2026. 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.