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510(k) Data Aggregation

    K Number
    K043194
    Device Name
    VOXAR 3D PRODUCT FAMILY
    Manufacturer
    VOXAR LIMITED
    Date Cleared
    2005-01-11

    (54 days)

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

    VOXAR LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Voxar 3D product family is a suite of products that is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpreting DICOM compliant tomographic medical imaging. The Voxar 3D product family provides several levels of functionality to the user .- - Basic analysis tools they use on a daily basis, such as 2D review, orthogonal . multi planar reconstructions (mpr's), oblique mpr's, curved / cross - curved MPR's, slab MPR's AveiP, MIP, MinIP, measurements, annotations, reporting, distribution, etc. - Tools for in depth analysis, such as segmentation, enescopic review, colour VR . slab, 3D volume review, path definition and boundary detection, PET imagery analysis, etc - Specialist tools and workflow enhancements for specific clinical applications . which provide targeted workflows, custom UI, targeted measurement and reporting functions including colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography), calcium scoring (which is intended for non - invasive identification and quantification of calcifieatherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms), Vessel analysis (which is intended for the qualative and quantative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc
    Device Description
    Not Found
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    K Number
    K020140
    Device Name
    VOXAR'S CALCIUM SCORING PRODUCT
    Manufacturer
    VOXAR LIMITED
    Date Cleared
    2002-01-28

    (12 days)

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

    VOXAR LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Voxar Calcium Scoring is a PC based software only application intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using IST image data and clinically accepted calcium scoring algorithms. Voxar calcium scoring is intended to be used by radiologists and other clinicians.
    Device Description
    PC based software only application
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    K Number
    K012072
    Device Name
    VOXAR VC, MODEL 1.0
    Manufacturer
    VOXAR LIMITED
    Date Cleared
    2001-07-12

    (10 days)

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

    VOXAR LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Voxar Colonscreen is a software application for the display and 3D visualization of medical image data derived from CT and MR scans for the purpose of assisting in patient review and detection of colon polyps, cancers and other lesions by providing display and reporting facilities to enhance workflow. It is intended for use by radiologists, clinicians and referring physicians to process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.
    Device Description
    Voxar Colonscreen is a software application for the display and 3D visualization of medical image data derived from CT and MR scans.
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    K Number
    K992654
    Device Name
    PLUG 'N VIEW 3D, VERSION 1.0
    Manufacturer
    VOXAR LIMITED
    Date Cleared
    1999-11-05

    (88 days)

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

    VOXAR LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Plug 'n View 3D is a software application for the display and 3D visualization of medical image data derived from CT and MRI scans. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.
    Device Description
    Plug 'n View 3D is a software application for the display and 3D visualization of medical image data derived from CT and MRI scans. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.
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