Product code

AI devices with FDA product code QEA — Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Product code QEA (“Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid” in openFDA) covers 4 devices on the FDA AI-enabled list, from 2 companies. Most are reviewed by the Neurology panel (4). The most recent decision was EYE-SYNC on October 2, 2021.

4AI devices

2Companies

2018First decision

2021-10-02Latest decision

Trend: devices per year

2018201920202021

AI devices with FDA product code QEA — Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid per year: 2018 1, 2019 1, 2020 1, 2021 1

Top companies

Oculogica, Inc.3
SyncThink, Inc.1

All 4 devices, newest first

EYE-SYNCSyncThink, Inc. · NeurologyK2029272021-10-02
EyeBOXOculogica, Inc. · NeurologyK2018412020-09-06
EyeBOXOculogica, Inc. · NeurologyK1911832019-07-31
EyeBOXOculogica, Inc. · NeurologyDEN1700912018-12-28