# Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
> **Product code: PIW** · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1450
## Classification
- **FDA Product Code:** PIW
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 882.1450
- **Review panel:** NE
- **Medical specialty:** Neurology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 9
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PIW)
---
*AI Analytics · CC0 1.0*