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    K Number
    K003325
    Device Name
    KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
    Manufacturer
    KARL STORZ IMAGING, INC.
    Date Cleared
    2001-04-27

    (185 days)

    Product Code
    FET,GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Karl Storz Imaging (KSI) New Camera Architecture (NCA) Video Imaging System is a color, television camera system intended for use with rigid or flexible endoscopes, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope and the endoscopic image can be displayed on any standard operating room video monitor.

    All standard endoscopic light sources may be used with New Camera Architecture (NCA) camera heads. The camera heads will be available in NTSC and PAL configurations.

    Device Description

    The Karl Storz Imaging (KSI) New Camera Architecture (NCA) Video Imaging System is a color, television camera system intended for use with rigid or flexible endoscopes.

    AI/ML Overview

    This is a notification for a Substantial Equivalence Determination. There is no information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

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