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510(k) Data Aggregation

    K Number
    K111642
    Device Name
    ONCO TRAC MODEL 1, 2, 4
    Manufacturer
    TRANSLATIONAL SCIENCES CORPORATION
    Date Cleared
    2011-11-18

    (158 days)

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

    TRANSLATIONAL SCIENCES CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OncoTrac™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MRI, measurement of lesions identified by trained users, tabulation of measurements, categorization of tumor response in accordance with user selected standards, and generation of a structured imaging report. OncoTrac™ is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. OncoTrac™ does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure, or function. OncoTrac™ is not intended for use for mammography.
    Device Description
    OncoTrac™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MRI. OncoTracTM runs on either a native or virtualized Microsoft Windows platform. Available functions include communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MRI. measurement of lesions identified by trained users, tabulation of measurements, categorization of tumor response in accordance with user selected standards, and generation of a structured imaging report. The user controls these functions with a system of interactive menus and tools.
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