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    K Number
    DEN190037
    Device Name
    NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
    Manufacturer
    AnX Robotica, Inc.
    Date Cleared
    2020-05-22

    (283 days)

    Product Code
    QKZ, OKZ
    Regulation Number
    876.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    AnX Robotica, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NaviCam Stomach Capsule is intended for visualization of the stomach of adults (≥22 years old) with a BMI less than 38. The system can be used in clinics and hospitals, including ER settings.
    Device Description
    The NaviCam Capsule Endoscopy System with NaviCam Stomach Capsule is an endoscopic capsule imaging system intended to obtain images of the stomach and duodenum. In contrast to passive capsule endoscopy systems, it uses external magnetic fields to allow the position of the capsule to be controlled by an operator. The NaviCam Capsule Endoscopy System with NaviCam Stomach Capsule consists of an ingestible capsule, a data recorder, a locator, and a controller.
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