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

    AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

    K Number: K122836 · Decision Jan 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    5
    Review Days
    116

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    Basic Information

    Device Name
    AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
    K Number
    K122836
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lorad, A Hologic Co.
    Date Received
    September 17, 2012
    Decision Date
    January 11, 2013
    Product Code
    IZH
    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
    IZH System, X-Ray, Mammographic

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