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510(k) Data Aggregation

    K Number
    K992560
    Device Name
    MAPS 10000
    Manufacturer
    Date Cleared
    1999-10-29

    (88 days)

    Product Code
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    WEB LINK MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MAPS 10000 is intended to acquire, process, display and maintain nuclear imaging studies obtained using compatible gamma camera systems.
    Device Description
    The MAPS 10000 is designed to acquire nuclear images as well as provide image display and processing, database utilities, and archiving utilities of nuclear imaging studies obtained using compatible existing acquisition software (subsystem) and gamma cameras. It is designed to be compatible with networked gamma camera and analogue camera systems using a windows-based operating system. MAPS 10000 includes a software program used to archive new nuclear imaging studies on a local disc drive or networked disc drive, to perform file management tasks on existing patient studies and data files (select, protect, copy, move, delete, and print); to import foreign patient studies and data; to display and process studies and data files; and to run pre-set and user-defined image protocols.
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