BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FDR D-EVO GL Flat Panel Detector System

    K Number: K152138 · Decision Nov 5, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    418
    Applicant Total
    70
    Review Days
    97

    Basic Information

    Device Name
    FDR D-EVO GL Flat Panel Detector System
    K Number
    K152138
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FUJIFILM MEDICAL SYSTEM U.S.A., INC.
    Date Received
    July 31, 2015
    Decision Date
    November 5, 2015
    Product Code
    MQB
    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
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

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