BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    NewTom 5G XL

    K Number: K183448 · Decision Mar 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    795
    Applicant Total
    2
    Review Days
    86

    Basic Information

    Device Name
    NewTom 5G XL
    K Number
    K183448
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cefla S.C.
    Date Received
    December 12, 2018
    Decision Date
    March 8, 2019
    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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