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

    DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST

    K Number: K922364 · Decision Sep 4, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    76
    Applicant Total
    146
    Review Days
    108

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    Basic Information

    Device Name
    DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST
    K Number
    K922364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Toshiba America Medical Systems, In.C
    Date Received
    May 19, 1992
    Decision Date
    September 4, 1992
    Product Code
    IXR
    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
    IXR Table, Radiographic, Tilting

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