# K162595: Trex_HD

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Decided: Nov 4, 2016 after 50 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 K042150 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131266: Trez_HD, Excel-Tech Ltd. (Xltek) (2014) Summary page 4.

## Indications for use
The Trex_HD is an electroencephalograph intended to be used to acquire, display, store and archive electroencephalographic signals, intended for electroencephalographic (EEG) or level 1-2 polysomnographic (PSG) recordings. The Trex_HD amplifier is designed to be used with Natus NeuroWorks™ or Natus SleepWorks™ software.

Source page: https://510kreport.com/device/K162595
Methodology: https://510kreport.com/methodology