FDA.reportPublic FDA data

NEUROSYNC, INC.

Matched from indexed company URL: NEUROSYNC INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30141331653014133165NEUROSYNC, INC.1N2026-01-01118 Washington Street Suite 14 Holliston MA US 01746

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860013612900EYE-SYNC - 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 display2. Android TabletThe 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.8554558500support@neurosync.health
00868096000300EYE-SYNC - X02617-221-3813support@syncthink.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2124201934226166K202927EYE-SYNCQEA2021-10-02
2124201934586279K152915EYE-SYNCGWN2016-01-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QEA12021-10-02
GWN12016-01-29

GUDID#

EYE-SYNC - 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 display2. Android TabletThe 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.

NEUROSYNC INC.

2025-03-12