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

    VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES

    K Number: K893739 · Decision Jul 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    190
    Review Days
    58

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    Basic Information

    Device Name
    VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
    K Number
    K893739
    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
    May 17, 1989
    Decision Date
    July 14, 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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