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510(k) Data Aggregation

    K Number
    K972215
    Device Name
    MEDIMAGE
    Date Cleared
    1997-11-19

    (159 days)

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

    VEPRO - COMPUTERSYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MEDImage will be used to acquire, display, process, archive, retrieve, and transmit diagnostic radiological images and information about these images in a single user or network environment. Typical users of MEDImage are trained medical professionals.
    Device Description
    MEDImage is a software package designed to acquire analogue and digital images from any modality, store and archive these images together with patient information on hard disk and/or on long-term media such as standard optical disks; search for and retrieve these images for re-consultation, processing and/or transmission. MEDImage utilizes industry standard equipment.
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