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510(k) Data Aggregation

    K Number
    K093689
    Device Name
    1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS
    Manufacturer
    MR MEDICAL SOLUTIONS LLC
    Date Cleared
    2010-08-31

    (274 days)

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

    MR MEDICAL SOLUTIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners. The coil is intended to facilitate complete MR imaging of the intracranial/extracranial neurovasculature and skull base. The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil and is indicated for use only under the supervision of a physician or certified MR technologist who is trained in the field of Diagnostic Resonance Imaging.
    Device Description
    The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners.
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