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

    QXLINK

    K Number: K092081 · Decision Jul 21, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    10
    Review Days
    12

    Basic Information

    Device Name
    QXLINK
    K Number
    K092081
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VIEWORKS CO., LTD.
    Date Received
    July 9, 2009
    Decision Date
    July 21, 2009
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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    K122866 VIVIX-S WITH VXVUE
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    K073056 DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9