Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Medical specialty
Neurology
Device class
2
Regulation number
882.1455
Review panel
NE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.