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510(k) Data Aggregation

    K Number
    K210415
    Device Name
    QSM software, QSMetric
    Manufacturer
    Date Cleared
    2021-07-22

    (161 days)

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

    Medimagemetric LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    QSM software (QSMetric™) is intended for use in the post-acquisition image enhancement of 3D MR images of the brain acquired using a gradient-echo sequence at 1.5T, 3T and 7T field strengths. QSM uses phase information to enhance contrast between tissues presenting magnetic susceptibility differences, such as deoxygenated blood, iron or calcium deposits. When used in combination with other clinical information, QSM may aid the qualified physicians in visualizing tissue structures with magnetic susceptibility contrasts and measuring their susceptibility values.
    Device Description
    The product QSMetric™, also referred to as QSM software, postprocesses gradient echo magnetic resonance (MR) images to depict tissue magnetic susceptibility contrast (local difference). Tissue susceptibility contrast sources include highly paramagnetic iron presented in deoxyhemoglobin, ferritin and hemosiderin, and diamagnetic calcification. Susceptibility contrast material of tissue in the MR scanner generates its own magnetic field according to the convolution law in magnetism. This tissue field with its dispersion in space causes MR image signal magnitude loss, creating contrasts in magnitude images. Therefore, the magnitude image is commonly used to indicate the presence of nearby tissue susceptibility contrast. In addition to magnitude images, a gradient echo MR scan results in also phase images. The tissue field causes MR image signal phase accrual, creating contrasts in phase images. The phase image of gradient echo MR data is the product of echo time and tissue field. Accordingly, the phase images from a gradient echo MR scan is processed using QSM to enhance the depiction of tissue susceptibility contrasts. QSM software works in conjunction with any FDA cleared third-party DICOM viewer as an image postprocessing solution in radiological service.
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