nordicBrainEx

GUDID 07090042059015

The nordicBrainEx Software is a post-processing application for dynamic MRI data developed with focus on ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for dynamic image analysis and visualization of MRI data, where signal changes over time are analyzed to determine various modality dependent functional parameters. The following algorithms provide the main functional analyses of the application. - BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity. - DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain. - DSC: Calculations of perfusion related parameters that provide information about the blood vessel structure and characteristics. Examples of such maps are blood volume, blood flow, time to peak, mean transit time and leakage. In addition to these specific functional analyses, the application also provides general visualization tools, a database for data handling, and a reporting feature. This is to ensure that the workflow of the application is optimized to ensure efficiency and high throughput in a clinical environment.

Nordicneurolab AS

MRI system application software

• Primary Device ID: 07090042059015
• NIH Device Record Key: f8e150a1-cba1-4c91-a088-5f20eae203e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nordicBrainEx
• Version Model Number: 2.3
• 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

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
• 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
• 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
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07090042059015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163324

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2017-05-07

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