BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

    K Number: K161009 · Decision Jul 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    795
    Applicant Total
    58
    Review Days
    102

    Basic Information

    Device Name
    Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
    K Number
    K161009
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Date Received
    April 11, 2016
    Decision Date
    July 22, 2016
    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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