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510(k) Data Aggregation

    K Number
    K213737
    Device Name
    Quantib ND
    Manufacturer
    Date Cleared
    2022-01-14

    (46 days)

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

    Quantib B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Quantib ND is a non-invasive medical imaging processing application that is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of magnetic resonance (MR) images. The Quantib ND output consists of segmentations, visualizations and volumetric measurements of brain structures and white matter hyperintensities. Volumetric measurements may be compared to reference centile data. It is intended to provide the trained medical professional with complementary information and assessment of MR brain images and to aid the trained medical professional in quantitative reporting.
    Device Description
    Quantib ND is an extension for Quantib Al Node software platform. It is intended for automatic labeling, visualization, and volumetric quantification of identifiable brain structures from magnetic resonance images (a 3D T1-weighted MR image for brain structure segmentation, with an additional T2-weighted FLAIR MR image for white matter hyperintensities (WMH) segmentation). The segmentation system relies on a number of atlases each consisting of a 3D T1-weighted MR image and a label map dividing the MR image into different tissue segments. Quantib ND provides quantitative information on both the absolute and relative volume of the segmented regions. The automatic WMH segmentation is to be reviewed and if necessary, edited by the user before validation of the segmentation, after which volumetric information is accessible. Quantib ND consists of 4 workflows: for both segmentation and quantification of brain structures as well as of white matter hyperintensities is there a single time-point analysis workflow, and a longitudinal workflow, which provides longitudinal analysis of images of two or more time-points. Quantib ND is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the radiology specialist in quantitative reporting.
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