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

    CLISIS SYSTEMS, Discovery RF180

    K Number: K213081 · Decision Oct 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    41
    Applicant Total
    7
    Review Days
    33

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    Basic Information

    Device Name
    CLISIS SYSTEMS, Discovery RF180
    K Number
    K213081
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1740
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    General Medical Merate S.P.A
    Date Received
    September 23, 2021
    Decision Date
    October 26, 2021
    Product Code
    IZF
    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
    IZF System, X-Ray, Tomographic

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