Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

QEA is the FDA product code for Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid, a class II device type, regulated under 21 CFR 882.1455. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 7 510(k) clearances under this code, the most recent dated 2026-06-05, and 2 recalls.