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510(k) Data Aggregation

    K Number
    K093810
    Device Name
    BF-NAVI
    Manufacturer
    KGT INC.
    Date Cleared
    2010-06-18

    (189 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    KGT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bf-NAVI is a virtual bronchoscopic navigation (VBN) software program designed to assist a 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. Bf-NAVI allows the physician to view a 3D representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. Bf-NAVI is intended for use only as a guidance tool and does not make any medical diagnosis.
    Device Description
    Bf-NAVI is a virtual bronchoscopic navigation (VBN) software program designed to assist a 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. Bf-NAVI allows the physician to view a 3D representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. Bf-NAVI is intended for use only as a guidance tool and does not make any medical diagnosis. The Bf-NAVI software is a self-contained Windows-based image software package. Using pulmonary CT slice data, the Bf-NAVI device helps the user in guiding endoscopic tools or catheters in the pulmonary tract. The Bf-NAVI allows the user to view computed tomography via Multi-Planar Reconstruction (MPR). The software uses the CT data to generate a 3D image of the tracheobronchial tree. The Bf-NAVI device does not interface directly with any CT or data collection equipment; the CT data is imported from files previously created on another device. The software does not perform any function which can not be accomplished manually by a trained operator utilizing manual tracing methods; the software is designed to assist in the compilation of the data to save time and prevent errors. The Bf-NAVI software has functions for loading, analyzing, saving data profiles and will generate screen displays from the results.
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