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

    Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)

    K Number: K163624 · Decision Jun 30, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    39
    Review Days
    190

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    Basic Information

    Device Name
    Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
    K Number
    K163624
    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 Systems U.S.A, Inc.
    Date Received
    December 22, 2016
    Decision Date
    June 30, 2017
    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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