BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    QXLink

    K Number: K161113 · Decision Aug 5, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    10
    Review Days
    107

    Basic Information

    Device Name
    QXLink
    K Number
    K161113
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    VIEWORKS CO., LTD.
    Date Received
    April 20, 2016
    Decision Date
    August 5, 2016
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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    Other Clearances by VIEWORKS CO., LTD.

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    K152855 VIVIX-S 1012N
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    K122865 VIVIX-S WIRELESS
    K122866 VIVIX-S WITH VXVUE
    K120020 VIVIX-S
    K092081 QXLINK
    K080553 DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
    K073056 DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9