# K200705: Nurochek System

- Pathway: 510(k) (Traditional)
- Applicant: Cryptych Pty, Ltd.
- Decided: Apr 23, 2020 after 36 days
- Product code: GWE (Stimulator, Photic, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K873535 (1987). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113785: Adherent Visual Stimulator Goggles, Anschel Technology, Inc. (2012) Summary page 4.
- K131383: X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software, Advanced Brain Monitoring, Inc. (2013) Summary page 4.

## Indications for use
The Nurochek System is intended for prescription use in healthcare facilities or clinical research environments for subjects ages 14 years and older. The Nurochek System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display and store electroencephalograms (EEGs) during the generation of VEPs. The Nurochek System only acquires and displays physiological signals: no claims are being made for use as a diagnostic criterion or for the analysis of the acquired signals with respect to the accuracy, precision and reliability.

Source page: https://510kreport.com/device/K200705
Methodology: https://510kreport.com/methodology