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510(k) Data Aggregation

    K Number
    K211983
    Device Name
    AMRA Profiler
    Manufacturer
    Date Cleared
    2021-11-24

    (152 days)

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

    AMRA Medical AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indicated for use as a magnetic resonance diagnostic device software application for non- invasive fat and muscle evaluation that enables the generation, display and review of 2D magnetic resonance medical image data. Designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the body including the liver. Other physical parameters derived from the images may also be produced. Provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of fat fraction in the liver, T2* and muscle volume. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
    Device Description
    Not Found
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    K Number
    K173749
    Device Name
    AMRA Profiler
    Manufacturer
    Date Cleared
    2018-12-06

    (363 days)

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

    AMRA Medical AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indicated for use as a magnetic resonance diagnostic device software application for non- invasive fat and muscle evaluation that enables the generation, display and review of 2D magnetic resonance medical image data. Designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the body including the liver. Other physical parameters derived from the images may also be produced. Provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of fat fraction in the liver, T2* and muscle volume. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
    Device Description
    Not Found
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