# K240593: VEEGix EEG System

- Pathway: 510(k) (Traditional)
- Applicant: NeuroServo, Inc.
- Decided: Aug 23, 2024 after 175 days
- Product code: OLT (Non-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 K875179 (1988). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213299: Wireless EEG System, Pascall Systems, Inc. (2022) Summary page 5.
- K221563: Neurosteer EEG Recorder, Neurosteer, Inc. (2022) Summary page 5.

## Indications for use
The VEEGIix EEG System, is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display. The VEEGIix EEG System, is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis. The VEEGIix EEG System, is intended for use in a hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings. The VEEGIix EEG System is indicated for use on patients 18 years of age or older and is to be used by licensed medical professionals who have been adequately trained in the use and interpretation of EEG data for determination of brain state. The VEEGIix EEG System does not provide any diagnostic conclusion about the patient's condition. The VEEGIix EEG System is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition. The VEEGIix EEG System is not intended for use in life support systems.

Source page: https://510kreport.com/device/K240593
Methodology: https://510kreport.com/methodology