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    K Number
    K972229
    Device Name
    IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM
    Manufacturer
    HEARTWARE, INC.
    Date Cleared
    1997-10-16

    (125 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEARTWARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ImageView™ Coronary Angiography Display and Review System is a computer program which can be used to view the results of an X-ray cardiac angiography procedure on a personal computer workstation. The digital image record of the X-ray exposures made during a catheterization procedure can be retrieved from a compact disk (CD) and displayed on a computer workstation monitor. ImageView™ also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.
    Device Description
    The ImageView™ Coronary Angiography Display and Review System is an angiographic image review software program. It is provided on a 3½-inch 1.44 MB floppy disk. The disk contains the installation program, ImageView™ executable files, a Readme file and Dynamic Link Library files. ImageView™ is designed to read and display angiographic images which have been stored using the DICOM 3.0 format for medical images.
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