# K190815: BrainScope TBI

- Pathway: 510(k) (Traditional)
- Applicant: Brainscope Company, Inc.
- Decided: Sep 11, 2019 after 166 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: 5 generations back to K801604 (1980). 21 ancestors in all.
2 later devices descend 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)
- K183241: BrainScope TBI (Model: Ahead 400), Brainscope Company, Inc. (2019) Summary page 5.

## Most influential descendants
- K231914: Nurochek-II System (2023), 1 descendant of its own
- K243426: Nurochek-Pro System (2025), 0 descendants of its own

## Indications for use
• BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury, and have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion/mild traumatic brain injury (mTBI)). • BrainScope TBI provides a multi-parameter measure (Concussion Index (CI)) to aid in the evaluation of concussion in patients between the ages of 13–25 years who present with a GCS score of 15 following a head injury within the past 72 hours (3 days), in conjunction with a standard neurological assessment of concussion. The CI is computed from a multivariate algorithm based on the patient’s electroencephalogram (EEG), augmented by neurocognitive measures and selected clinical symptoms. • The BrainScope TBI Structural Injury Classification (“SIC”) uses brain electrical activity (EEG) to determine the likelihood of structural brain injury visible on head CT for patients between the ages of 18-85 years (have a GCS score of 13 – 15), have sustained a closed head injury within the past 72 hours (3 days) who are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation. • BrainScope TBI provides a measure of brain function (EEG Brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment, in patients 18-85 years of age (have a GCS score of 13 – 15) who have sustained a closed head injury within the past 72 hours (3 days). • The BrainScope TBI 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 TBI 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. • BrainScope TBI also provides clinicians with quantitative measures of cognitive performance in patients 13-85 years of age to aid in the assessment of an individual’s level of cognitive function. These measures interact with the CI and can be used stand alone. • BrainScope TBI 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/K190815
Methodology: https://510kreport.com/methodology