nordicDSC

GUDID 07090042059053

nordicDSC is an image analysis module that can be integrated into hospital infrastructure to analyze dynamic susceptibility contrast enhanced (DSC) perfusion data obtained from Magnetic Resonance Imaging (MRI). The product can be deployed on the nordicMEDiVA platform, or as a plugin to other software offerings.

Nordicneurolab AS

MRI system application software

• Primary Device ID: 07090042059053
• NIH Device Record Key: 223383d9-5e93-40ca-993f-40f7ce785b76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nordicDSC
• Version Model Number: 23.04
• 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: 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	07090042059053 [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: 2024-02-20
• Device Publish Date: 2024-02-12

On-Brand Devices [nordicDSC]

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