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

    XELIS CARDIAC

    K Number: K111660 · Decision Sep 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    12
    Review Days
    91

    Basic Information

    Device Name
    XELIS CARDIAC
    K Number
    K111660
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    INFINITT CO., LTD.
    Date Received
    June 14, 2011
    Decision Date
    September 13, 2011
    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 INFINITT CO., LTD.

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    K082990 INFINITT XELIS
    K082706 INFINITT CARDIOLOGY PACS
    K052545 INFINITT G3 PACS
    K052284 REFORMAT GATEWAY
    K051715 STARPACS DENTAL
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