# K181179: BrainScope One

- Pathway: 510(k) (Special)
- Applicant: Brainscope Company, Inc.
- Decided: May 18, 2018 after 16 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: 3 generations back to K801604 (1980). 19 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161068: Ahead 300, Brainscope Company, Inc. (2016) Summary page 5.

## Most influential descendants
- K183241: BrainScope TBI (Model: Ahead 400) (2019), 3 descendants of its own
- K190815: BrainScope TBI (2019), 2 descendants of its own
- K231914: Nurochek-II System (2023), 1 descendant of its own
- K243426: Nurochek-Pro System (2025), 0 descendants of its own
- K181785: Modified BrainScope One (2018), 0 descendants of its own

## Indications for use
BrainScope One is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head CT, who sustained a closed head injury within 72 hours, present with a Glasgow Coma Scale score (GCS) of 13-15 (including concussion / mild Traumatic Brain Injury (mTBI)), and are between the ages of 18-85 years. The BrainScope One should not be used as a substitute for a CT scan. The BrainScope One device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient’s forehead. The BrainScope One calculates and displays raw measures for the following standard QEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user. A negative BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with no structural brain injury visible on head CT. A positive BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with a structural brain injury visible on head CT. An equivocal BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation. The BrainScope One provides a measure of brain function (EEG Brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG). BrainScope One also provides clinicians with quantitative measures of cognitive performance to aid in the assessment of an individual’s level of cognitive function. These measures do not interact with any other device measures, and are stand alone. BrainScope One also stores and displays electronic versions of standardized clinical assessment tools that should be used in accordance with the assessment tools’ general instructions. These tools do not interact with any other device measures, and are stand alone.

Source page: https://510kreport.com/device/K181179
Methodology: https://510kreport.com/methodology