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

    2000 X-RAY - TOMOGRAPHIC

    K Number: K931815 · Decision Aug 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    41
    Applicant Total
    7
    Review Days
    137

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    Basic Information

    Device Name
    2000 X-RAY - TOMOGRAPHIC
    K Number
    K931815
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1740
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imaging Sciences Intl., Inc.
    Date Received
    April 8, 1993
    Decision Date
    August 23, 1993
    Product Code
    IZF
    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
    IZF System, X-Ray, Tomographic

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