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510(k) Data Aggregation

    K Number
    K240943
    Device Name
    LungVision
    Date Cleared
    2024-10-01

    (179 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BodyVision Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
    Device Description
    The Lung Vision System is designed to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures. The System is intended to assist the guidance of endobronchial tools to areas of interest inside a patient's lungs. The System allows the user to mark lesion locations and pathways to marked lesions using a patient's CT scan. During the endoscopic procedure, the System overlays planning information on real-time fluoroscopic images to guide endobronchial tool navigation. The System also provides tomographic images for lesion identification, as well as 3D views for understanding tool and lesion proximity and orientation. The System is designed to be integrated with fluoroscopic imaging systems and external displays. The Lung Vision system includes a main unit and a tablet. Image processing algorithms are executed on the main unit and the tablet is used as a primary method of interacting with the system.
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