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510(k) Data Aggregation

    K Number
    K131737
    Device Name
    SUPERNOVA C5 MRI SYSTEM
    Date Cleared
    2014-10-23

    (497 days)

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

    LIAONING KAMPO MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Supernova C5 is intended for use as a diagnostic imaging device which can produce transverse, sagittal, coronal and oblique cross-sectional images of the internal structure of the human head, body or extremities. The images produced by MRI 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. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination
    Device Description
    The Supernova C5 is a 0.35T permanent magnet MRI system. It is composed of Magnet and Magnet Enclosure, RF Coils , Patient Couch, System Cabinet, computer system. The system software based on Windows XP or Windows 7 is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.
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