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510(k) Data Aggregation

    K Number
    K970782
    Device Name
    IMAGING JET SYSTEM
    Date Cleared
    1997-11-13

    (254 days)

    Product Code
    Regulation Number
    892.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL ROBOTIC DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Imaging Jet System provides physicians with a three dimensional image of an endoscope inside a patient.
    Device Description
    The Imaging Jet is an endoscopic accessory that provides a spatial view of an endoscope inside a patient. When in use, the sensor catheter is inserted into the biopsy channel of an endoscope inside a patient. The sensor catheter measures the shape of a scope and sends sensory signals to a computer for calculating and displaying the image on the computer screen. A complete Imaging Jet system consists of the following major components: (1). a computer which governs the operation of the whole system, calculates the scope spatial image and displays the image; (2). a signal processing unit which acquires and processes the sensory signals and supplies them to the computer for image calculation; (3). a sensor catheter which is a long flexible rod with sensors embedded inside in its head portion; (4). a sensor catheter transport unit which is used to insert and withdraw sensor catheter into and from the biopsy channel of a scope; and (5). a mobile stand for transporting the whole system.
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