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

    Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I

    K Number: K203042 · Decision Dec 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    97
    Review Days
    65

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    Basic Information

    Device Name
    Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
    K Number
    K203042
    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 6, 2020
    Decision Date
    December 10, 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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