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

    VISTA MR 2055 HP SYSTEM

    K Number: K895151 · Decision Oct 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    152
    Registration Numbers
    152
    Same Product Code
    1071
    Applicant Total
    181
    Review Days
    81

    Basic Information

    Device Name
    VISTA MR 2055 HP SYSTEM
    K Number
    K895151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Date Received
    August 10, 1989
    Decision Date
    October 30, 1989
    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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