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

    MECALL CLISIS SYSTEMS, Discovery RF180

    K Number: K173395 · Decision May 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    7
    Review Days
    203

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    Basic Information

    Device Name
    MECALL CLISIS SYSTEMS, Discovery RF180
    K Number
    K173395
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    General Medical Merate S.P.A
    Date Received
    October 30, 2017
    Decision Date
    May 21, 2018
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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