EyeBOX is an AI-enabled medical device from Oculogica, Inc. that the U.S. FDA granted through De Novo DEN170091 on December 28, 2018. Its lead review panel is Neurology and its primary product code is QEA (Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid).
See also FDA-cleared AI neurology devices in 2018, all FDA AI clearances in 2018, top neurology AI devices.
Key facts
| Submission number | DEN170091 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Oculogica, Inc. |
| Lead review panel | Neurology |
| Primary product code | QEA — Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| Applicant (openFDA) | Oculogica, Inc. |
| Applicant location | New York, NY, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 882.1455 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. EyeBOX went through this pathway (DEN170091).
openFDA lists it as a Class 2 device under 21 CFR 882.1455. Class II devices are moderate risk and are subject to general and special controls.
Product code QEA covers 4 devices on the FDA AI list. By decision date, this device is #1 of 4 under that code. Oculogica, Inc. has 3 AI-enabled devices on the list, and the Neurology panel accounts for 73 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
Similar devices (product code QEA)
- EYE-SYNCSyncThink, Inc. · Neurology
- EyeBOXOculogica, Inc. · Neurology
- EyeBOXOculogica, Inc. · Neurology