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510(k) Data Aggregation

    K Number
    K022877
    Device Name
    OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM
    Manufacturer
    Date Cleared
    2003-02-05

    (159 days)

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

    VISION CHIPS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OBserver Ultrasound Reporting and Imaging System is intended to automate and enhance the process by which ultrasound examination information is entered and by which ultrasound images are stored and reviewed by physicians in the field of maternal-fetal medicine. The system also provides significant research data for academic institutions.
    Device Description
    The Vision Chips ultrasound reporting and imaging system consists of comprehensive reporting and image archiving software for use in the field of obstetrics and gynecology. It enables physicians to generate reports documenting the results of ultrasound exams and to view the images that were captured during those exams. The system also enables physicians to perform research on all data that have been entered into the program. Ultrasound machines may transfer ASCII text based information to the system by means of a serial interface. Ultrasound images are received either by means of a standard frame grabber connected to the ultrasound video output or directly across the network using DICOM protocols. Still images are stored as standard jpegs or in DICOM format, cine loops are stored as mpegs, AVIs or in multi frame DICOM format. All hardware required for the system, including computers, storage devices, monitors and frame grabbers, consists of standard, off the shelf components.
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