# K191432: cortiQ PRO

- Pathway: 510(k) (Traditional)
- Applicant: G.Tec Medical Engineering GmbH
- Decided: Jan 24, 2020 after 240 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: 4 generations back to K001564 (2000). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 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.
- K123255: g.HIamp, G.Tec Medical Engineering GmbH (2012) Summary page 4.

## Indications for use
The system is intended to statistically evaluate brain activity reflected in a broad band of high-gamma frequencies in the human electroencephalogram (EEG). These measures should always be interpreted in conjunction with review of the original EEG waveform. cortiQ PRO is intended for the evaluation of intracranial EEG recorded with the g.HIamp.

Source page: https://510kreport.com/device/K191432
Methodology: https://510kreport.com/methodology