Inroom Viewing Device

GUDID 07090042051033

NordicNeuroLab’s LCD monitor (NNL MRI InroomViewingDevice LCD 40) is a complete, state-of-the-art solution designed specifically for use in the MR environment. LCD 40 is part of NordicNeuroLab’s VisualSystem. 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 or by an in-room LCD monitor. LCD 40 is a 40 inch LCD (Liquid Crystal Display) monitor, compatible with MR system up to 3T. The LCD monitor uses standard DVI display signal, and can be connected to any computer or video output device with digital outputs. The LCD monitor are capable to show video signals in 4K UHD format (3840x2160 pixels) The LCD monitor is equipped with a integrated VGA camera.

Nordicneurolab AS

Visual stimulator

• Primary Device ID: 07090042051033
• NIH Device Record Key: b1e483db-9cca-4912-b2c8-5a0a42a54ecf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inroom Viewing Device
• Version Model Number: LDC 3.0
• 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: 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	07090042051033 [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: 4
• Public Version Date: 2019-06-28
• Device Publish Date: 2016-09-24

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