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510(k) Data Aggregation

    K Number
    K221590
    Device Name
    NaviCam Small Bowel Capsule Endoscopy System
    Manufacturer
    ANKON Technologies Co., Ltd.
    Date Cleared
    2022-12-02

    (183 days)

    Product Code
    NEZ
    Regulation Number
    876.1300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANKON Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NaviCam Small Bowel Capsule Endoscopy System is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
    Device Description
    The NaviCam Small Bowel Capsule Endoscopy System is an endoscopic capsule imaging system intended to obtain images of the small bowel. It is comprised of the following components: 1. Capsule (AKES-11SW, AKES-11SI): The disposable, ingestible NaviCam Small Bowel Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via an RF communication channel to the NaviCam Data Recorder located outside the body. 2. Data recorder (AKR-1, AKRI-1): The Data Recorder is an external receiving and recording unit that receives and stores the acquired images from the capsule. 3. ESView Software: The ESView is a software application for processing, analyzing, storing, and viewing the acquired images collected from the NaviCam Data Recorder to create a video of the images. The software also includes a reporting function to create detailed clinical reports and a capsule endoscopy atlas. 4. Locator: The Locator is a handheld device that is used to turn the NaviCam Capsule on. It is also used for determining if the capsule is still in the body when the patient is not sure whether he/she expelled it.
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