4 devices · 4 companies · 2014 to 2019
Product code PIW: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
4 devices under product code PIW, 2014 to 2019, from 4 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid. 21 CFR 882.1450, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| BrainScope TBIK190815 · 510(k) | BrainScope Company, Inc. | Neurology | database entry | |
| Ahead 300K161068 · 510(k) | BRAINSCOPE COMPANY INC | Neurology | database entry | |
| Brainscope Ahead 200K143643 · 510(k) | BRAINSCOPE COMPANY, INC. | Neurology | database entry | |
| BrainScope Ahead 100DEN140025 · De Novo | BRAINSCOPE COMPANY, INC | Neurology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.