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510(k) Data Aggregation

    K Number
    K160666
    Device Name
    Dentiq3D
    Date Cleared
    2016-10-05

    (210 days)

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

    3D INDUSTRIAL IMAGING CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dentiq3D is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Dentiq3D is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
    Device Description
    Dentiq3D is a dental image software platform for the 3D visualization and analysis of volume data. Dentig3D is optimized for analyzing volume data from CT scan and enables users to examine volume data through 3D visualization, 2D analysis, and various MPR functions to manipulate CT images. The functions include canal tracing, implant simulation, volume segmentation and airway measurement. The following are the major functions of Dentiq3D. - Visualizes CT volume data - Supports various types of data - Measures 3D object - Analyzes and filters volume data - Publishes various forms of report - 3D visualization by using GPU - Loads and saves project files - Restores (Undo) or repeats (Redo) tasks based on operation history - Supports a user-friendly interface
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