Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Neurology · 21 CFR 882.1455
A traumatic brain injury eye movement assessment aid is a prescription device that uses a patients tracked eye movements to provide an interpretation of the functional condition of the patients brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- NeuroSync, Inc.Open, ClassifiedJul 11, 2025
NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary so
Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023.
Z-2114-2025 · View FDA record ↗ - OCULOGICATerminatedUnknown
EyeBOX Model OCL 02
A review of the user manual revealed that two precaution statements were missing.
Z-2398-2019 · View FDA record ↗
Registered firms
7 firms currently registered for this product code
510(k) clearances
7 clearances for this product code
- Oculogica, Inc.Jun 5, 2026
K254086 · EyeBOX SNAP
- Oculogica, Inc.Apr 4, 2025
K242116 · EyeBOX EBX-4.1
- Oculogica, Inc.Dec 22, 2021
K212310 · EyeBOX (Model EBX-4)
- Syncthink, Inc.Oct 2, 2021
K202927 · EYE-SYNC
- Oculogica, Inc.Sep 6, 2020
K201841 · EyeBOX
- Oculogica, Inc.Jul 31, 2019
K191183 · EyeBOX
- Oculogica, Inc.Dec 28, 2018
DEN170091 · EyeBOX