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

    Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

    K Number: K192832 · Decision Feb 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    795
    Applicant Total
    87
    Review Days
    142

    Basic Information

    Device Name
    Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
    K Number
    K192832
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Canon Medical Systems Corporation
    Date Received
    October 2, 2019
    Decision Date
    February 21, 2020
    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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