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

    CANON X-RAY 35MM CINE CAMERA CSI-35

    K Number: K853983 · Decision Oct 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    11
    Applicant Total
    48
    Review Days
    19

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    Basic Information

    Device Name
    CANON X-RAY 35MM CINE CAMERA CSI-35
    K Number
    K853983
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1620
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Canon USA, Inc.
    Date Received
    September 27, 1985
    Decision Date
    October 16, 1985
    Product Code
    IZJ
    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
    IZJ Camera, X-Ray, Fluorographic, Cine Or Spot

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