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

    MOLECULAR BREAST IMAGING SOFTWARE

    K Number: K111731 · Decision Sep 15, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    2
    Review Days
    87

    Basic Information

    Device Name
    MOLECULAR BREAST IMAGING SOFTWARE
    K Number
    K111731
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GAMMA MEDICA-IDEAS INCORPORATED
    Date Received
    June 20, 2011
    Decision Date
    September 15, 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 GAMMA MEDICA-IDEAS INCORPORATED

    K Number Device Name
    K111791 LUMAGEM MOLECULAR BREAST IMAGING SYSTEM