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

    COLLIMAX X-RAY COLLIMATOR # R-182

    K Number: K801168 · Decision Jul 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    54

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    Basic Information

    Device Name
    COLLIMAX X-RAY COLLIMATOR # R-182
    K Number
    K801168
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Ito X-Ray Corp.
    Date Received
    May 15, 1980
    Decision Date
    July 8, 1980
    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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