# K120447: X4

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Brain Monitoring, Inc.
- Decided: Jun 20, 2012 after 127 days
- Product code: OMC (Reduced- 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: 5 generations back to K873535 (1987). 18 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112514: Apnea Risk Evaluation System (Ares), Advanced Brain Monitoring, Inc. (2012) Summary page 1.

## Most influential descendants
- K130013: X4 System (2013), 17 descendants of its own
- K131383: X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software (2013), 14 descendants of its own
- 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

## Indications for use
The X4 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals from adult patients. The X4 System acquires, records, transmits and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMVG), accelerometer, acoustical and photoplethesmographic signals. The X4 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/K120447
Methodology: https://510kreport.com/methodology