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510(k) Data Aggregation

    K Number
    K183593
    Device Name
    Lung Vision System
    Manufacturer
    Body Vision Medical Ltd.
    Date Cleared
    2019-04-18

    (118 days)

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

    Body Vision Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 (K163622) 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 Lung Vision System is designed to assist the physician in guiding endobronchial tools towards the target area of interest inside the patient lungs. Prior to the endoscopic procedure the system allows planning the target location and the path to the target area on the CT scan. During the endoscopic procedure the system overlays planned data over fluoroscopic images to support endobronchial tool navigation towards the area of interest. The system does not include the Fluoroscope, Bronchoscope or the external monitor. Lung Vision system includes a main unit and a tablet vs. the previous PC based hardware platform. Image processing algorithms are executed on the main unit and the tablet is used as a primary method of interacting with the system. The Tablet is for planning but is not for diagnostic purposes. Both can perform the following functions: segment previously acquired DICOM 3D CT image data, register DICOM 3D CT image data with live fluoroscopic X-ray image, overlay the segmented 3D CT dataset over a live fluoroscopic X-ray image of the same anatomy, obtained on a Fluoroscopic system.
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    K Number
    K172955
    Device Name
    LungVision Tool
    Manufacturer
    Body Vision Medical Ltd.
    Date Cleared
    2018-04-26

    (212 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Body Vision Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endotherapy accessories and ultrasound probe to guide the endotherapy accessories or ultrasound probe to the target area, specifically within the respiratory system.
    Device Description
    Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area, specifically within the respiratory system. LungVision tool is designed to be used by pulmonologists or thoracic surgeons during pulmonary procedures. The LungVision Tool is designed to be connected to a standard Bronchoscope Instrument Port. The Lung Vision Bronchoscope Adaptor is used to connect the LungVision Handle to the Bronchoscope instrument port / working channel entrance, and to allow the physician to release the tool from the bronchoscope. The current adaptor is for the Olympus Bronchoscope Model BF-1T160. More types of Bronchoscope Adaptors for other bronchoscopy brands and models. Lung Vision Tool Sheath can accommodate endo-therapy accessories and ultrasound probes with an outer diameter up to 1.9 mm.
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    K Number
    K163622
    Device Name
    Lung Vision
    Manufacturer
    BODY VISION MEDICAL LTD.
    Date Cleared
    2017-05-11

    (140 days)

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

    BODY VISION MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lung Vision 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 LungVision System is designed enabling 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. The Lung Vision System is designed to assist the physician in guiding endobronchial tools towards the target area of interest inside the patient lungs. Prior to the endoscopic procedure the system allows planning the target location and the path to the target area on the CT scan. During the endoscopic procedure the system overlays planned data over fluoroscopic images to support endobronchial tool navigation towards the area of interest. The system does not include the Fluoroscope, Bronchoscope or the external monitor. Lung Vision image processing algorithms are executed on a PC based hardware platform, which can perform the following functions: - segment previously acquired DICOM 3D CT image data, . - register DICOM 3D CT image data with live fluoroscopic X-ray image - overlay the segmented 3D CT dataset over a live fluoroscopic X-ray image of the same anatomy, ● obtained on a Fluoroscopic system.
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