# K051825: Cognitrace

- Pathway: 510(k) (Traditional)
- Applicant: Eemagine Medical Imaging Solutions GmbH
- Decided: Sep 12, 2005 after 69 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- 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: 2 generations back to K874685 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991054: Bravo Multi-Modality System, Nicolet Biomedical, Inc. (1999) Summary page 1.

## Indications for use
Intended to record and display EEG and EP (evoked potential) data in the clinic and hospital. It is intended to aid in the diagnosis and monitoring of potential disorders of the central and peripheral nervous system.

Source page: https://510kreport.com/device/K051825
Methodology: https://510kreport.com/methodology