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

    STEREO COLLIMATOR RF-T SERIES

    K Number: K920733 · Decision Apr 16, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    22
    Applicant Total
    90
    Review Days
    58

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    Basic Information

    Device Name
    STEREO COLLIMATOR RF-T SERIES
    K Number
    K920733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shimadzu Medical Systems
    Date Received
    February 18, 1992
    Decision Date
    April 16, 1992
    Product Code
    IZW
    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
    IZW Collimator, Automatic, Radiographic

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