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510(k) Data Aggregation

    K Number
    K233822
    Device Name
    i2Contour
    Manufacturer
    Date Cleared
    2024-08-08

    (251 days)

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

    MRIMath LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MRIMath i2contour is intended for the semi-automatic labeling, visualization, and volumetric quantification of WHO grade 4 glioblastoma (GBM) from a set of standard MRI images of male or female patients 18 years of age or older who are known to have pathologically proven glioblastoma. Volumetric measurements may be compared to past measurements if available. MRIMath i2contour is not to be used for primary diagnosis and is not intended to be the sole diagnostic metric.
    Device Description
    The MRIMath i2Contour is a web-based software platform designed for the contouring and segmentation of the T1c and FLAIR sequences of the MRIs of patients already diagnosed with GBM. It combines AI with a user interface (UI) for review, manual contouring, and approval. The software is intended to be used by trained medical professionals as an aid in the tumor contouring process. Review by a trained professional is a requirement for completion. The AI algorithm within MRIMath i2Contour generates an initial tumor contour, which serves as a starting point for medical professionals to complete the contouring process manually. It is important to note that the software does not alter the original MRI images and is not intended for turnor detection or diagnostic purposes. MRIMath i2Contour is specifically designed to generate turnor volume contours for GBM. It is not intended for use with images of other brain tumor types.
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