# K131383: X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Brain Monitoring, Inc.
- Decided: Nov 27, 2013 after 197 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: 7 generations back to K873535 (1987). 20 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130013: X4 System, Advanced Brain Monitoring, Inc. (2013) Summary page 1.

## Most influential descendants
- K141316: Cognision Eeg/EP System (2015), 7 descendants of its own
- K171781: eVox System (2017), 6 descendants of its own
- K192753: NeuralScan System (2020), 3 descendants of its own
- K172735: WR19 System (2018), 3 descendants of its own
- K233403: Flexset System (2024), 1 descendant of its own

## Indications for use
The X-Series System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, transmit, display and store physiological signals from patients ages 6 and older. The X-Series system requires operation by a trained technician. The X-Series System acquires, transmits, displays and stores electroencephalogram (EEG), electrooculogramn (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer signals. The X-Series System 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/K131383
Methodology: https://510kreport.com/methodology