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510(k) Data Aggregation

    K Number
    K153429
    Device Name
    SmartView 3D Option
    Manufacturer
    GE HANGWEI MEDICAL SYSTEM CO., LTD
    Date Cleared
    2016-03-09

    (105 days)

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

    GE HANGWEI MEDICAL SYSTEM CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smart View 3D option is used as part of a head or whole body CT interventional procedure when the physician desires to obtain a visualization, 3D orientation, and localization of the needle in patients of all ages. SmartView 3D can automatically detect various sized needles during CT interventional procedures. SmartView 3D reconstructs and displays the traditional 2D images, and immediately thereafter additionally displays Multiple Planar Reconstruction images from a reconstruction in an orthogonal reference frame aligned with the needle 's orientation where the needle tip is at the origin. This additional information may aid in guidance and/or monitoring during interventional procedures.
    Device Description
    The GE SmartView 3D Option is for use with a GE CT system. SmartView 3D is an enhanced software option to the current SmartView Option application (predicate device: K973168). The SmartView 3D Option is designed to be used during CT-guided interventional procedures with the ability to detect needles and produce, in a needlebased geometry, orthogonal 3D reformats. SmartView 3D displays the oblique Multiple Planar Reconstruction (MPR) images of the needle and provides 3D information of the needle orientation. The SmartView Option is intended to be used during CT interventional procedures with either a continuous fluoro acquisition mode or a step-andshoot, single segment rotation acquisition mode, both of which create 2D axial images using the CT scanner's reference frame. When applied, the SmartView 3D option allows the user to acquire image data from a step-and-shoot, single segment rotation acquisition, which it then uses for the three MPR reconstructions (Needle-sagittal plane, Needle-axial plane, Needle-tip plane) that are able to be displayed simultaneously. SmartView 3D also displays 2D axial images reconstructed from the same acquisition. The 3D interventional viewports automatically update each time an acquisition is initiated with the foot pedal. SmartView 3D provides both the 2D axial reconstructions as well as the three MPR reconstructions which provide the physician with additional information for needle position visualization and localization for CT intervention procedures.
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