Devices · Oculogica, Inc.

EyeBOX

Oculogica, Inc. is listed for EyeBOX (DEN170091). The FDA list gives December 28, 2018 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the De Novo 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 “Unknown.” 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/denovo.cfm?id=DEN170091

Official FDA database record

Date of final decision

December 28, 2018

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

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned