BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇷🇸 Serbia

    Visaris Avanse

    K Number: K150725 · Decision Jun 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    2
    Review Days
    80

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    Basic Information

    Device Name
    Visaris Avanse
    K Number
    K150725
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Visaris D.O.O. Belgrade
    Date Received
    March 20, 2015
    Decision Date
    June 8, 2015
    Product Code
    KPR
    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
    KPR System, X-Ray, Stationary

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    Other Clearances by Visaris D.O.O. Belgrade

    K Number Device Name
    K160620 Visaris Vision® (Vision C, Vision U. Vision V, Vision X)