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510(k) Data Aggregation

    K Number
    K110487
    Device Name
    FLEXIBLE CARDIAC COIL
    Date Cleared
    2011-04-19

    (56 days)

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

    LBDS HOLDING COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1.5T MRI systems are intended for use as NMR devices that produce images that (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Flexible Cardiac Coil is indicated for use with Philips 1.5T MRJ systems in the following anatomic regions and with the designated nuclei. Regions: Heart and associated structures in the thoracic region. Nuclei Excited: Hydrogen
    Device Description
    Flexible Cardiac Coil
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