QEA

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Product code

QEA

Device name

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Device class

Class 2

21 CFR

21 CFR 882.1455

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)

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

FDA classification 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.

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: 2026-06-05.

2 summaries are archived here for direct download.