# K253015: Cognitive Function Neuroimaging (cfNI) Software (1.0.0)

- Pathway: 510(k) (Traditional)
- Applicant: VoxNeuro, Inc.
- Decided: Jun 12, 2026 after 266 days
- Product code: OLU (Normalizing Quantitative Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K801604 (1980). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202588: BNA Platform, Elminda, Ltd. (2020) Summary page 5.

## Indications for use
The Cognitive Function Neuroimaging (cfNI) software is to be used by qualified healthcare professionals for the digital post-hoc statistical analysis of the human electroencephalogram (“EEG”), including event-related potentials (“ERPs”). This device is indicated for use in individuals 18 to 70 years of age, and in conjunction with Resting State, Auditory Oddball, Go No-Go, Continuous Visual Memory Test, and Eriksen Flanker tasks.

Source page: https://510kreport.com/device/K253015
Methodology: https://510kreport.com/methodology