BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Nuclear Magnetic Resonance Imaging

    PMA: P840063 · Supplement: S002 · Decision Jan 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    152
    Registration Numbers
    152

    Basic Information

    Device Name
    System, Nuclear Magnetic Resonance Imaging
    Trade Name
    GYROSCAN(TM)
    PMA Number
    P840063
    Supplement Number
    S002
    Device Class
    FDA Class 2
    Product Code
    LNH
    Generic Name
    System, nuclear magnetic resonance imaging
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 30, 1987
    Date Received
    October 31, 1986
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNH System, Nuclear Magnetic Resonance Imaging