Eye Tracker Camera

GUDID 07090042052023

Nordicneurolab AS

Eye movement analysis system

• Primary Device ID: 07090042052023
• NIH Device Record Key: 7682f94e-cc92-4acb-baf7-4df3b86dfb58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eye Tracker Camera
• Version Model Number: ETC 2.0
• Company DUNS: 671280238
• Company Name: Nordicneurolab AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4755707095
• Email: customerservice@nordicneurolab
• Phone: +4755707095
• Email: customerservice@nordicneurolab.com
• Phone: +4755707095
• Email: customerservice@nordicneurolab.com
• Phone: +4755707095
• Email: customerservice@nordicneurolab.com
• Phone: +4755707095
• Email: customerservice@nordicneurolab.com
• Phone: +4755707095
• Email: customerservice@nordicneurolab.com
• Phone: +4755707095
• Email: customerservice@nordicneurolab.com
• Phone: +4755707095
• Email: customerservice@nordicneurolab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07090042052023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092253

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-31

Devices Manufactured by Nordicneurolab AS

• 07090042052122 - Visual System Power Supply: 2025-04-14 Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HD Shielded enclosure containing the Power Supply Unit for t
• 07090042052115 - Visual System HD: 2025-03-12 The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presente
• 07090042059084 - nordicMEDIVA: 2024-11-07 nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pi
• 07090042059077 - nordicMEDIVA: 2024-07-23 nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pi
• 07090042059053 - nordicDSC: 2024-02-20 nordicDSC is an image analysis module that can be integrated into hospital infrastructure to analyze dynamic susceptibility cont
• 07090042059046 - nordicDSC: 2022-09-21
• 07090042052078 - VisualSystem Power Cable (VPC): 2021-02-08 The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presente
• 07090042052108 - Visual System HD: 2021-02-08 The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presente