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510(k) Data Aggregation

    K Number
    K123708
    Device Name
    SPINE COIL
    Date Cleared
    2013-04-10

    (128 days)

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

    USA PARAMED MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the SPINE COIL is to enable the MrOpen K101295 systems designed by Paramed to perform MR scan of the human spine either in the conventional recumbent position or with the patient sitting or standing (weight-bearing). The SPINE COIL inherits the same limitations of the Tomograph. The SPINE COIL enables the MRI System to which it is applied to acquire images of the Spine in transverse, sagittal, coronal and oblique cross-sectional directions. The images which are produced correspond to spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
    Device Description
    The proposed SPINE COIL is a surface coil aimed to the Spine district. It is characterized by the fact of being flexible. This is done to increase patient comfort.
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