Visual System HD

GUDID 07090042052085

The VisualSystem HD 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: 07090042052085
• NIH Device Record Key: b0ec34aa-6b81-4167-aacc-ffd91ac1ef23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visual System HD
• Version Model Number: VHD-1.1
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07090042052085 [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

On-Brand Devices [Visual System HD]

• 07090042052085: The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded
• 07090042052108: The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded
• 07090042052115: The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded