BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Nuclear Magnetic Resonance Imaging

    PMA: P830074 · Supplement: S017 · Decision Jul 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    152
    Registration Numbers
    152

    Basic Information

    Device Name
    System, Nuclear Magnetic Resonance Imaging
    Trade Name
    GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
    PMA Number
    P830074
    Supplement Number
    S017
    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
    July 29, 1988
    Date Received
    July 18, 1988
    Supplement Type
    THIRTY DAY TRACK
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    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