Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Product Code: QEA

Neurology General Optical Products / Medical

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.

Applicable Standards: None

Code of Federal Regulations: 882.1455


Radiation TypeOptical
Radition SafetyRadiation E
Annual ReportsRadiation Emitting Electronic Product Codes // Qui

Products Classified as QEA

3808Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Total Product Life Cycle (TPLC) Devices

3808Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Pre-market Notifications for QEA

K212310EyeBOX (Model EBX-4)Oculogica, Inc.
K202927EYE-SYNCSyncThink, Inc.
K201841EyeBOXOculogica, Inc.
K191183EyeBOXOculogica, Inc.

Global Unique Device Identification Database

00810051680003Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.