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

    RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT

    K Number: K894643 · Decision Dec 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    8
    Review Days
    143

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    Basic Information

    Device Name
    RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT
    K Number
    K894643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Lorad Medical Systems, Inc.
    Date Received
    July 24, 1989
    Decision Date
    December 14, 1989
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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