# K240420: NeuroField Analysis Suite

- Pathway: 510(k) (Traditional)
- Applicant: Neurofield, Inc.
- Decided: Sep 20, 2024 after 220 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: 10 generations back to K873535 (1987). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041263: Neuroguide Analysis System, Applied Neuroscience, Inc. (2004) Summary page 5.
- K171781: eVox System, Evoke Neuroscience, Inc. (2017) Summary page 5.

## Indications for use
The NeuroField Analysis Suite is to be used by qualified medical and qualified clinical professionals for the display and storage of electrical activity of a patient’s brain, including the post-hoc statistical evaluation of the human electroencephalogram (EEG) and event-related potentials (ERP).

Source page: https://510kreport.com/device/K240420
Methodology: https://510kreport.com/methodology