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

    GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM

    K Number: K113341 · Decision May 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    100
    Review Days
    171

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    Basic Information

    Device Name
    GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
    K Number
    K113341
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Medical Systems America, Inc.
    Date Received
    November 14, 2011
    Decision Date
    May 3, 2012
    Product Code
    JAK
    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
    JAK System, X-Ray, Tomography, Computed

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