4 devices · 2 companies · 2018 to 2021
Product code QEA: Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
4 devices under product code QEA, 2018 to 2021, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid. 21 CFR 882.1455, Class II. A traumatic brain injury eye movement assessment aid is a prescription device that uses a patients tracked eye movements to provide an interpretation of the functional condition of the patients brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| EYE-SYNCK202927 · 510(k) | SyncThink, Inc. | Neurology | database entry | |
| EyeBOXK201841 · 510(k) | Oculogica, Inc. | Neurology | database entry | |
| EyeBOXK191183 · 510(k) | Oculogica, Inc. | Neurology | database entry | |
| EyeBOXDEN170091 · De Novo | Oculogica, Inc. | Neurology | database entry |
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