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510(k) Data Aggregation

    K Number
    K241333
    Device Name
    Geniant Cranial (Navigated Neurosurgical Positioning Robot)
    Manufacturer
    Koh Young Technology Inc.
    Date Cleared
    2025-01-17

    (252 days)

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

    Koh Young Technology Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to aid in locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons for navigating compatible surgical instruments in open or percutaneous procedures. The device is indicated for any neurosurgical procedure in which stereotactic neurosurgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to anatomy images.
    Device Description
    Geniant Cranial is a hardware platform that supports real-time surgical navigation using medical patient images. The application software reprocesses the CT or MR images of the patient acquired before surgery. It displays the contents on the software screen in various fluoroscopy directions (axial, sagittal and coronal). Before surgery, the surgeon can create and save one or more surgical routes to simulate. The surgeon may create and manipulate one or more 3D models of human anatomy before the surgery. During surgery, the system tracks the position of special surgical tools in the patient's anatomy and continuously updates the positions of the surgical tools in these images. The application software can also show you how the actual position and path during surgery relate to the pre-operative plan and guide the surgeon to follow the planned trajectory. The real-time location information obtained through Genial can help guide the surgeon's decision and the surgical route.
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