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510(k) Data Aggregation

    K Number
    K121449
    Device Name
    DIRECTPATH
    Manufacturer
    CYBERNET SYSTEMS CO., LTD.
    Date Cleared
    2012-07-10

    (56 days)

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

    CYBERNET SYSTEMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DirectPath is a virtual bronchoscopic navigation software program designed to assist the physician during bronchoscopic examination. The main purpose of the software is to generate a tracheobronchial tree using chest CT scan data in order to help the physician find an optimal bronchial route to the target region. The DirectPath software allows the physician to view a three-dimensional representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. DirectPath is intended for use only as a guidance tool and does not make any medical diagnosis.
    Device Description
    The DirectPath is a virtual bronchoscopic navigation software program designed to assist the physician during a bronchoscopic examination. The main purpose of the software is to generate a tracheobronchial tree using chest CT scan data in order to help the physician find an optimal bronchial route to the target region. The DirectPath software allows the physician to view a three-dimensional representation of the bronchial tree that displays virtual images of the inside surface of the bronchi, DirectPath is intended for use only as a guidance tool and does not make any medical diagnosis. DirectPath is a Windows-based image software package. It is designed to capture pulmonary CT slice data and display results to assist the user in guiding endoscopic tools or catheters in the pulmonary tract. The software utilizes data from a CT scan to generate a three-dimensional image of the bronchus. DirectPath provides computed tomography viewing via Multi-Planar Reconstruction (MPR) to generate the three-dimensional image. DirectPath does not interface directly with any CT or data collection equipment; CT datasets are delivered via external storage devices (basically CD, DVD and USB Flash memory).
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