Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

PIW is the FDA product code for Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid, a class II device type, regulated under 21 CFR 882.1450. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 2025-03-27, and no recalls.