# K962447: Equinox Digital Eeg System

- Pathway: 510(k) (Traditional)
- Applicant: Physiometrix, Inc.
- Decided: Dec 12, 1996 after 171 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: 1 generation back to K905435 (1991). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930080: E*Net Neuromonitoring System, Physiometrix, Inc. (1993) Summary page 1.
- K905435: Uniquant, Neuroconcepts, Inc. (1991) 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
- K221963: Cumulus Functional Neurophysiology Platform (2023), 1 descendant of its own
- K253767: UB ERP System (2026), 0 descendants of its own

## Indications for use
The Equinox™ System has the same intended use as the Neuro Concepts UNIQUANT™ System, that is preserving the full fidelity of the original EEG waveform data in the EEG patient population while providing tools for displaying and printing EEG waveforms for review and interpretation by trained health care professionals.

Source page: https://510kreport.com/device/K962447
Methodology: https://510kreport.com/methodology