Control Room Interface

GUDID 07090042052061

Control Room Interface (CRI) is part of Visual System HD. CRI is the interface unit for video signal in (HDMI) and eye tracking video out (HDMI). The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays, Visual System HD.

Nordicneurolab AS

Visual stimulator

• Primary Device ID: 07090042052061
• NIH Device Record Key: b8c2c345-5d65-40ed-9e89-f6cf8163dc40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control Room Interface
• Version Model Number: CRI-1.0
• Company DUNS: 671280238
• Company Name: Nordicneurolab AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07090042052061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191032

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-03-01

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