PIW

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Product code

PIW

Device name

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Device class

Class 2

21 CFR

21 CFR 882.1450

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

9 (all years; only the last 3 years are listed here)

FDA classification definition

A prescription device that uses a patient¿s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient¿s brain in the setting of trauma. The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-03-27.

2 summaries are archived here for direct download.