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510(k) Data Aggregation

    K Number
    K021913
    Device Name
    CALSCOR SOFTWARE
    Manufacturer
    3D MED CO., LTD.
    Date Cleared
    2002-09-06

    (87 days)

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

    3D MED CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CalScoR Software is intended to be used with the Rapidia software by a trained physician for the review and analysis of CT images as an aid in cardiac analysis.
    Device Description
    CalScoR is a Windows-compatible software program that runs with the previously cleared Rapidia Software (K012290). The Rapidia Software is a fast, practical, and accurate tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of CT and MRI images using the most advanced graphics-rendering technology. CalScoR can specify the location of calcium in images, calculate the calcium score based on Agaston's method display the percentile of the score with the graph, and issue reports.
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    K Number
    K012290
    Device Name
    RAPIDIA
    Manufacturer
    3D MED CO., LTD.
    Date Cleared
    2001-09-28

    (70 days)

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

    3D MED CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rapidia® is a software package intended for viewing and manipulating DICOM-compliant medical images from CT (computerized tomography) and MR (magnetic resonance) scanners. Rapidia can be used for real-time viewing, image manipulation, segmentation, 3D volume and surface rendering, virtual endoscopy, and reporting.
    Device Description
    Rapidia® is a fast, practical and accurate tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of CT and MRI images using the most advanced graphics rendering technology. The proposed software provides volume rendering (VR), maximum/minimum intensity projection 3D (MIP/MinIP), surface shaded display (SSD), multi-planar reconstruction (MPR), virtual endoscopy, 2D image editing and segmentation (2D), and issues reports.
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