# Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
> **Product code: QEA** · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1455
## Classification
- **FDA Product Code:** QEA
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 882.1455
- **Review panel:** NE
- **Medical specialty:** Neurology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.

## Market data
- **Cleared 510(k) submissions:** 6
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QEA)
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