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510(k) Data Aggregation

    K Number
    K250551
    Device Name
    4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
    Manufacturer
    Shenzhen Sophway Technology Co., Ltd.
    Date Cleared
    2025-10-02

    (219 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K151011
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is used to connect with an optical endoscope during the endoscopic diagnosis, treatment, and observation. And to capture, process and transmit images in the human body cavity under the field of view observed by the endoscope to the monitor.

    Device Description

    The 4K Endoscopic Camera System consists of a camera control unit and a 4K camera head.
    The device is intended to be used to connect with an optical endoscope during the endoscopic diagnosis and/or treatment/surgery, and to capture, process and transmit images in the human body cavity under the field of view observed by the endoscope to the monitor.
    There are 4 models of the device. The hardware configuration of the device of 4 models are same, and difference is different functions which opened up through software.

    AI/ML Overview

    N/A

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