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    K Number
    K243429
    Device Name
    HJY VisualNext 3D Endoscopic Vision System
    Manufacturer
    HJY Smart Medical Device Co., Ltd.
    Date Cleared
    2025-05-21

    (197 days)

    Product Code
    GWG
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    HJY Smart Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a self-help tool for individuals aged 18 or older with diagnosed depression. It is intended to be used in addition to usual care and not as a replacement for it.
    Device Description
    [Input Description text here]
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    K Number
    K222735
    Device Name
    HJY VisualNext Endoscopic Vision System
    Manufacturer
    HJY Smart Medical Device Co., Ltd.
    Date Cleared
    2023-07-28

    (322 days)

    Product Code
    GWG
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    HJY Smart Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HJY VisualNext™ Endoscopic Vision System is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of structures within the brain during neurological surgical procedures as well as for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy.
    Device Description
    The HJY VisualNext™ Endoscopic Vision System is a system used for viewing internal surgical sites during surgical procedures. The system consists of the following components: - . Endoscope Control Unit (ECU) (Model number: HDSES01) - . Endoscope (Model number: HDSE201) The endoscope is physically connected via a 5m BNC cable to the Endoscope Control Unit (ECU). The Endoscope consists of 2 LED lamps and a CMOS camera, embedded in the proximal end of a rigid metal arthroscope, which captures the image and transmits to and is processed by the Endoscope Control Unit (ECU), subsequently output to and presented on an external monitor. Images are recordable and markable for further analysis. The Endoscope Control Unit (ECU) is not connectable to intranet or Internet.
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