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510(k) Data Aggregation

    K Number
    K092102
    Device Name
    NORDICBRAINEX SOFTWARE, VERSION 1.0
    Manufacturer
    NORDICIMAGINGLAB AS
    Date Cleared
    2009-08-25

    (42 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORDICIMAGINGLAB AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicBrainEx provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis. BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity. DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain. Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data of the brain, showing properties of changes in contrast over time where such techniques are useful or necessary.
    Device Description
    The nordicBrainEx·Software is a post-processing application for functional MRI data developed with a view to ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for processing and analyzing BOLD fMRI and DTI data, in addition to efficient and easy to use tools for visualization and report generation. The application workflow has been optimized to ensure efficiency and high throughput in a clinical environment.
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    K Number
    K090546
    Device Name
    MODIFICATION TO NORDICICE SOFTWARE
    Manufacturer
    NORDICIMAGINGLAB AS
    Date Cleared
    2009-06-08

    (98 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORDICIMAGINGLAB AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    nordiclCE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians-The software-runs on a standard "off-the-shelf" PC -workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordic!CE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRJ, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis. BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity. DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain. Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data of the brain, showing properties of changes in contrast over time where such techniques are useful or necessary.
    Device Description
    nordiclCE – Nordic Image Control and Evaluation software – is a medical viewing, analysis, and processing package developed with a view to ease of use and high performance on a standard Windows platform. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive functionality for dynamic image analysis and processing/display of functional MRI (fMRI) data. The main user of the program will be imaging professionals who need to visualize and analyze images taken primarily from a MRI system.
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    K Number
    K082441
    Device Name
    NORDICICE SOFTWARE
    Manufacturer
    NORDICIMAGINGLAB AS
    Date Cleared
    2008-11-21

    (88 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORDICIMAGINGLAB AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis. BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity. DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain. Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary.
    Device Description
    nordicICE (nlCE) - Nordic Image Control and Evaluation software - is a medical viewing, analysis, and processing package developed with a view to ease of use and high performance on a standard Windows platform. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive functionality for dynamic image analysis and processing/display of functional MRI (fMRI) data. The main user of the program will be imaging professionals who need to visualize and analyze images taken primarily from a MRI system.
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