# K170138: Neuronaute

- Pathway: 510(k) (Traditional)
- Applicant: Bioserenity
- Decided: Dec 26, 2017 after 343 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: 8 generations back to K873535 (1987). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131383: X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software, Advanced Brain Monitoring, Inc. (2013) Summary page 4.
- K061148: Rhythmlink Disc Electrodes, Rhythmlink International, LLC (2006) Summary page 4.

## Indications for use
The Neuronaute is a medical, wireless and mobile equipment, which allows acquisition, record, storage, transmission and displaying of electroencephalogram (EEG) from adult patients. It can be used with patients in health care facility (data acquisition and reporting) or clinical research environment. The Neuronaute requires operation by a trained healthcare professional. The Neuronaute only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

Source page: https://510kreport.com/device/K170138
Methodology: https://510kreport.com/methodology