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

    DIAL X COLLIMATOR MODEL A&B

    K Number: K771689 · Decision Sep 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    16
    Applicant Total
    23
    Review Days
    8

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    Basic Information

    Device Name
    DIAL X COLLIMATOR MODEL A&B
    K Number
    K771689
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Bennett X-Ray Corp.
    Date Received
    September 6, 1977
    Decision Date
    September 14, 1977
    Product Code
    IZX
    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
    IZX Collimator, Manual, Radiographic

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