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510(k) Data Aggregation

    K Number
    K220072
    Device Name
    Sinobot X1
    Date Cleared
    2023-06-18

    (524 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sinovation (Beijing) Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sinobot X1 is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate.
    Device Description
    The Sinobot X1 device is a computer-aided, robotized image-guided interactive surgical system. The system integrates medical image processing technology with robotic surgery technology to assist the surgeon during brain surgeries. The system allows the surgeon to utilize the spatial positioning technology to pre-plan the instruments on medical images and provide stable, precise and reproducible guidance in accordance with the planning. The device consists of a robotic stand with a compact robotic arm and a touch screen. The robotic arm can attach to different types of instruments and be changed based on the intended surgical procedures. For different surgical procedures a biopsy needle, stimulation or recording electrode could be attached to the device. The 3D Optical scanner is an optical device combined by a projector and a visible light camera. Which provide a high-resolution point cloud scanning of patients' facial skin surface in order to perform patient registration.
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