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.

Clearance details

Applicant: VoxNeuro, Inc.
Product code: 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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