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510(k) Data Aggregation

    K Number
    K043134
    Device Name
    METRX WORKSTATION
    Date Cleared
    2004-12-13

    (31 days)

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

    MEDICAL METRX SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Metrx Workstation is intended for users to segment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Metrx also provides the user with tools to better visualize and analyze the processed data. Metrx data may be outputted as the source data for Preview® Treatment Planning Software. The Metrx product is not intended to provide medical diagnosis or a recommended treatment approach.
    Device Description
    The Metrx Workstation is a software product that is intended for users to segment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Metrx also provides the user with tools to better visualize and analyze the processed data. Metrx data may be outputted as the source data for Preview® Treatment Planning Software. The Metrx Workstation product is not intended to provide medical diagnosis or a recommended treatment approach.
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