Cognitive Function Neuroimaging (cfNI) Software (1.0.0)— 510(k) K253015

Name: FDA 510(k) clearance K253015
Creator: U.S. Food and Drug Administration
Published: 2026-06-12

Substantially Equivalent

VoxNeuro, Inc.

FDA 510(k) clearance K253015 for Cognitive Function Neuroimaging (cfNI) Software (1.0.0), Substantially Equivalent on 2026-06-12. Applicant: VoxNeuro, Inc.. Device class: 2.

Summary

VoxNeuro's Cognitive Function Neuroimaging (cfNI) Software (1.0.0) is filed under OLU, normalizing quantitative electroencephalograph software. The record doesn't describe the software beyond its name and the code name.

Class II, 21 CFR 882.1400. Neurology is both the classification panel and the review panel. It was a Traditional 510(k).

VoxNeuro filed from Toronto, Canada. The decision came 266 calendar days after FDA received it (September 19, 2025 to June 12, 2026).

Clearance details

Applicant: VoxNeuro, Inc.
Product code: Product code OLU
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2025-09-19
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.