EYE-SYNC

NEUROSYNC INC. · Model X03 · UDI-DI 00860013612900

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The NeuroSync EYE-SYNC device is a portable, fully enclosed eye tracking environment with two primary components: 1. Eye Tracker (head-mounted device) with eye tracking sensor and display 2. Android Tablet The eye tracker is a Pico Neo 3 Pro Eye with embedded sensors provided by Tobii Tech. It is mounted to the subject's face and held in place using a strap. The eye tracking sensor includes two cameras (one for each eye) to capture eye movement data. Eye gaze tracking is performed using a proprietary implementation of the pupil-corneal reaction method. The integrated display within the headset provides a binocular visual field and operates as part of the standalone VR system, running on Qualcomm Snapdragon XR2 hardware. The headset processes eye-tracking data internally and supports USB-C connectivity. The display receives eye tracking sensor information for post-processing, manages sensor calibration, provides binocular visual display to the subject, and interfaces with the Android tablet over Bluetooth. Eye gaze tracking and visual display is combined to provide several assessment paradigms to characterize subject eye tracking performance.

Recalls

Date	Firm	Reason
2015-07-21	Neuro Kinetics, Inc.	The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.
2015-04-30	Neuro Kinetics, Inc.	complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
2014-07-09	Integra LifeSciences Corp.	Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.
2013-11-21	Neuro Kinetics, Inc.	The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.