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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Nordicneurolab AS
1.1
In Commercial Distribution

  • 07090042059046 ()


  • MRI system application software
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
2.3
In Commercial Distribution

  • 07090042059015 ()


  • MRI system application software
Central Nursing Station or Central Monitoring System
SKANRAY TECHNOLOGIES LIMITED
F3-87-390-0075-46
In Commercial Distribution

  • 18904269451537 ()


  • Centralized patient monitor
Central Nursing Station or Central Monitoring System
SKANRAY TECHNOLOGIES LIMITED
F3-87-390-0074-49
In Commercial Distribution

  • 18904269451520 ()


  • Centralized patient monitor
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220461 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220430 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220348 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220300 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220294 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220270 ()


  • Portable basic diagnostic x-ray system, digital
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