# K231914: Nurochek-II System

- Pathway: 510(k) (Traditional)
- Applicant: Headsafe Mfg Pty, Ltd.
- Decided: Dec 27, 2023 after 181 days
- Product code: PIW (Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.1450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K801604 (1980). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190815: BrainScope TBI, Brainscope Company, Inc. (2019) Summary page 5.

## Most influential descendants
- K243426: Nurochek-Pro System (2025), 0 descendants of its own

## Indications for use
The Nurochek-II System is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment. The Nurochek-II 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. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 16 and 46 years old who have sustained a potential head injury in the past 72 hours (3 days).

Source page: https://510kreport.com/device/K231914
Methodology: https://510kreport.com/methodology