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

    CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31

    K Number: K003689 · Decision Jan 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    48
    Review Days
    398

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    Basic Information

    Device Name
    CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
    K Number
    K003689
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1630
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Canon USA, Inc.
    Date Received
    November 30, 2000
    Decision Date
    January 2, 2002
    Product Code
    IXK
    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
    IXK System, Imaging, X-Ray, Electrostatic

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