BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MR RADIATION ONCOLOGY OPTIONS

    K Number: K102155 · Decision Aug 31, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    152
    Registration Numbers
    152
    Same Product Code
    1071
    Applicant Total
    61
    Review Days
    32

    Basic Information

    Device Name
    MR RADIATION ONCOLOGY OPTIONS
    K Number
    K102155
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GE MEDICAL SYSTEMS, LLC
    Date Received
    July 30, 2010
    Decision Date
    August 31, 2010
    Product Code
    LNH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNH System, Nuclear Magnetic Resonance Imaging

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