DeviceClearance

Product code QEA— Neurology

EyeBOX

Classification name
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Device class
Class 2
Regulation
21 CFR 882.1455
Advisory panel
Neurology
Total cleared
7
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QEA under 21 CFR 882.1455, via openFDA

Market context for product code QEA

FDA has cleared 7 devices under product code QEA between 2018 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QEA

Recent clearances under product code QEA

Data sourced from openFDA. This site is unofficial and independent of the FDA.