# K212684: BrainView QEEG Software

- Pathway: 510(k) (Traditional)
- Applicant: Medeia, Inc.
- Decided: Jan 28, 2023 after 522 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: 3 generations back to K801604 (1980). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 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 4.

## Indications for use
The BrainView QEEG Software Package is to be used by qualified medical or clinical professionals for the statistical evaluation of the human electroencephalogram (EEG).

Source page: https://510kreport.com/device/K212684
Methodology: https://510kreport.com/methodology