BCIwiki (bciwiki.com) — VoxNeuro, Inc. received an FDA 510(k) decision of Substantially Equivalent for Cognitive Function Neuroimaging (cfNI) Software (1.0.0) on June 12, 2026, under submission number K253015. The submission followed the Traditional 510(k) clearance pathway.
FDA lists the product under the device classification name Normalizing Quantitative Electroencephalograph Software. It is a Class 2 device under regulation number 882.1400, assigned to the Neurology advisory committee. Normalizing quantitative EEG software compares an individual's EEG metrics against a reference population database before reporting, supporting objective assessment of cognitive function.