# K192753: NeuralScan System

- Pathway: 510(k) (Traditional)
- Applicant: Medeia, Inc.
- Decided: Mar 17, 2020 after 169 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: 10 generations back to K873535 (1987). 45 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171781: eVox System, Evoke Neuroscience, Inc. (2017) Summary page 4.
- K141316: Cognision Eeg/EP System, Neuronetrix Solutions (2015) Summary page 4.

## Most influential descendants
- K221963: Cumulus Functional Neurophysiology Platform (2023), 1 descendant of its own
- K253767: UB ERP System (2026), 0 descendants of its own
- K221959: Q21 (2023), 0 descendants of its own

## Indications for use
The NeuralScan System is intended for the acquisition, display, analysis, and storage, of electrical activity of a patient’s brain including electroencephalograph (EEG) and Event-related Potentials (ERP), obtained by placing two or more electrodes on the head to aid in diagnosis.

Source page: https://510kreport.com/device/K192753
Methodology: https://510kreport.com/methodology