EyeBOX is an AI-enabled medical device from Oculogica, Inc. that the U.S. FDA cleared through 510(k) K201841 on September 6, 2020. Its lead review panel is Neurology and its primary product code is QEA (Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid).
See also all FDA AI clearances in 2020, top neurology AI devices.
Key facts
| Submission number | K201841 |
|---|---|
| Pathway | 510(k) |
| 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 | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. EyeBOX went through this pathway (K201841).
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 #3 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