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

    VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)

    K Number: K061613 · Decision Jan 10, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    215

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    Basic Information

    Device Name
    VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)
    K Number
    K061613
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tripath Imaging
    Date Received
    June 9, 2006
    Decision Date
    January 10, 2007
    Product Code
    NQN
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

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