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510(k) Data Aggregation

    K Number
    K130242
    Device Name
    MAVEN PRO
    Manufacturer
    NSEQUENCE
    Date Cleared
    2013-08-29

    (210 days)

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

    NSEQUENCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Maven Pro is intended for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a Dental CT scanner. It is also intended for use as a planning and simulation software in the placement of dental implants and surgical treatment.
    Device Description
    Maven Pro Graphic Station is a fully-featured 3D imaging application in medicine. Its unique open architecture and modular framework make customization and integration options trivial. On demand, nSequence will create a fully customized 3D medical imaging solution. Maven Pro Graphic Station supports all the common 3D medical imaging functionalities used by professional doctors to support their diagnosis. It includes various Volume and IsoSurface rendering, segmentation tools, masking and sculpting, MPR, 2D and 3D measurement and analysis tools. Since 2D imaging is still an important feature, it is possible to switch with a single click to a 2D view, use an even more sophisticated MPR view or switch back to the 3D view. Maven Pro software is characterized by its intuitive user interface, 2D, MPR and 3D imaging, prime image quality and extensive visualization options, fast image rendering, measurement and analysis tools, and easy integrated reporting.
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