← FDA Medical Device Classifications

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

QEA · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1455

Classification

FDA Product Code
QEA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.1455
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
6
Registered establishments
2

Source

Authoritative
FDA Device Classification database
Machine
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