nordicDSC

GUDID 07090042059046

Nordicneurolab AS

MRI system application software

• Primary Device ID: 07090042059046
• NIH Device Record Key: a1fa7510-2943-4ee3-ba3a-398379335733
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nordicDSC
• Version Model Number: 1.1
• Company DUNS: 671280238
• Company Name: Nordicneurolab AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07090042059046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212720

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2022-09-21
• Device Publish Date: 2022-09-13

On-Brand Devices [nordicDSC]

• 07090042059046: 1.1
• 07090042059053: nordicDSC is an image analysis module that can be integrated into hospital infrastructure to ana