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510(k) Data Aggregation

    K Number
    K014011
    Device Name
    CANVAS N-VAS-D 2.0
    Manufacturer
    Date Cleared
    2002-02-05

    (62 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASSOL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    N-VAS-D is designed and intended for use as a supporting tool to non-invasive assessment of the vascular system. Intended purposes are: - Supporting clinical diagnoses about the flow velocity and volume flow through the vascular system. - Supporting subsequent clinical decision making purposes. - Supporting clinical post-operation and follow-up evaluation about the flow velocity and volume flow throughout the vascular system. - Supporting the use in the treatment planning using computer modeling of the vascular system.
    Device Description
    N-VAS-D is a software tool used to non-invasively measure blood flow in the vascular system. N-VAS-D works on the images acquired from an MRI. It uses Time-of-Flight MRI images obtained via digital network to generate a 3D image. N-VAS-D allows fast scan acquisition time, fast post processing, and accurate flow measurement. N-VAS-D provides accurate vessel identification y using stereo visualization. N-VAS-D gives velocity and volume flow as a function of time, and other derived data such as mean velocity and volumetric flow rate. N-VAS-D generates a web browser compatible flow report that shows both flow results and images. The N-VAS-D 2.0 includes three modules: 3DP, 3DFLOW and AUTOREPORT. N-VAS-D works on the images acquired from an MRI. It uses Time-of-Flight MRI images obtained via digital network to generate a 3D image. N-VAS-D allows fast scan acquisition time, fast post processing, and accurate flow measurement. N-VAS-D provides accurate vessel identification by using stereo visualization. N-VAS-D gives velocity and volume flow as a function of time, and other derived data such as mean velocity and volumetric flow rate. N-VAS-D generates a web browser compatible flow report that shows both flow results and images.
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