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510(k) Data Aggregation

    K Number
    K070831
    Device Name
    VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION
    Manufacturer
    BARCOVIEW MIS EDINBURGH
    Date Cleared
    2007-05-22

    (57 days)

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

    BARCOVIEW MIS EDINBURGH

    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 tools for the reading and review of a DICOM compliant series of medical images which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data.
    Device Description
    The Voxar 3D product family provides several levels of functionality: - Basic analysis tools used on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions . (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, and distribution. - Tools for in-depth analysis, such as regional segmentation of anatomical structures within the image data. . endoscopic review, color volume rendering of finite thickness data cross-sections, 3D review of data volumes, path definition through vascular and other tubular structures and boundary detection. - Specialist tools and workflow enhancements for specific clinical applications which provide directed workflows. custom User Interfaces, and special measurement and reporting functions optimized for the specific clinical applications. Specialized clinical applications include: - Colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other o lesions using tomographic Colonography), - Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic o angiographic studies to evaluate occlusive and aneurismal diseases and the effectiveness of stents and stent grafts) - Coronary Artery Analysis (which is intended for the qualitative and quantitative analysis of coronary o arteries to evaluate occlusive and aneurismal disease), - Functional Cardiac Analysis (which is intended to evaluate the functional characteristics of the heart), O - PET-CT Reading (which is intended for analysis of lesions using FDG imaging from hybrid PET-CT o scanners)
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    K Number
    K061326
    Device Name
    VOXAR 3D ENTERPRISE WITH CARDIAMETRIX
    Manufacturer
    BARCOVIEW MIS EDINBURGH
    Date Cleared
    2006-05-25

    (15 days)

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

    BARCOVIEW MIS EDINBURGH

    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 tools for the reading and review of a DICOM compliant series of medical images which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical Imaging professionals to aid in their reading and review of such data. The Voxar 3D product family provides several levels of functionality: - Basic analysis tools used on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved MPRs, slab MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, and distribution. - Tools for in-depth analysis, such as regional segmentation of anatomical structures within the image data, endoscopic review, color volume rendering of finite thickness data cross-sections, 3D review of data volumes, path definition through vescular and other tubular structures, boundary detection, and PET image analysis. - Specialist tools and workflow enhancements for specific clinical applications which provide directed workflows, custom User Interfaces, and special measurement and reporting functions optimized for the specific clinical applications. Also included are computer-sided detection signithms which are the user on possible structures of interest. Specialized dinical applications include: - Colon Screening (which Is intended for the screening of patients for colonic polyps, turnours and other o lesions using tomographic Colonography), - Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic o anglographic studies to evaluate occusive and aneurismal diseases and the effectiveness of stents and stent grafts) - Coronary analysis (which is Intended for the qualitative and quantitative analysis of coronary 0 arteries to evaluate occlusive and aneurismal disease). - Functional cardiac analysis (which is intended to evaluate the functional characteristics of the heart),
    Device Description
    Not Found
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    K Number
    K060505
    Device Name
    VOXAR 3D ENTERPRISE, MODEL 6.1
    Manufacturer
    BARCOVIEW MIS EDINBURGH
    Date Cleared
    2006-03-29

    (30 days)

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

    BARCOVIEW MIS EDINBURGH

    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 (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, distribution, etc - Tools for in-depth analysis, such as segmentation, endoscopic 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 calcified atherosclerotic plaques in the coronary arteries using tornographic medical image data and clinically accepted calcium scoring algorithms), Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc.
    Device Description
    Not Found
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