Devices · Oculogica, Inc.

EyeBOX

Oculogica, Inc. is listed for EyeBOX (K201841). The FDA list gives September 6, 2020 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QEA as “Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201841

Official FDA database record

Date of final decision

September 6, 2020

Company on the FDA list

Oculogica, Inc.

Lead panel

Neurology

Primary product code

QEA

openFDA device name for the code

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Device class

2

Regulation number

882.1455

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary