BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇳 China

    NaviCam ProScan

    K Number: DEN230027 · Decision Dec 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    242

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    Basic Information

    Device Name
    NaviCam ProScan
    K Number
    DEN230027
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    876.1540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Ankon Technologies Co., Ltd.
    Date Received
    April 14, 2023
    Decision Date
    December 12, 2023
    Product Code
    QZF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QZF Gastrointestinal Capsule Endoscopy Analysis Software Device

    Similar 510(k) Clearances

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    Other Clearances by Ankon Technologies Co., Ltd.

    K Number Device Name
    K221590 NaviCam Small Bowel Capsule Endoscopy System