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510(k) Data Aggregation

    K Number
    K131896
    Device Name
    SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM
    Date Cleared
    2014-02-28

    (248 days)

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

    SUZHOU ANKE MEDICAL SYSTEM CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SuperVan 1.5T Magnetic Resonance Imaging System is a MRI system that produces transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
    Device Description
    The proposed device, SuperVan 1.5T, is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in an open gantry design. It's indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. These images when interpreted by a trained physician, yield information that may assist in diagnosis. The MRI system is composed of magnet, RF Amplifier, Gradient Amplifier, RF Coils, control computer, intercom system and water chiller. The system software, AnkeStation, based on Windows XP operating system is an interactive program with user friendly interface.
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