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510(k) Data Aggregation

    K Number
    K192969
    Device Name
    Ezra Plexo Software
    Manufacturer
    Date Cleared
    2020-07-10

    (261 days)

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

    Ezra AI Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, 3D- visualization, and comparison of MR medical images. The images can be viewed in a number of output formats including volume rendering. Ezra Plexo Software enables visualization of information that would otherwise have to be visually compared disjointedly. Ezra Plexo Software is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, and documentation of any such lesions. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Ezra Plexo Software is a complement to these standard procedures.
    Device Description
    Ezra Plexo is a medical image application for 2D and 3D visualization, comparison, and manipulation of medical images. Plexo can be accessed through a web browser. It provides radiologists the ability to view and manipulate volumetric data such as MRI. The product allows volumetric segmentation of regions of interest, while enabling users to edit such segmentations and to take quantitative measurements. Plexo does not interface directly with the MR scanner or any other data collection equipment. Instead, it uploads data files previously generated by such equipment. Its functionality is independent of the acquisition equipment vendor. Its analysis results are available on screen and can be saved for review.
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