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510(k) Data Aggregation

    K Number
    K072258
    Device Name
    BI-RADS COMPANION
    Date Cleared
    2008-05-16

    (276 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALMEN LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BI-RADS Companion™ ("BRC") is a computer-aided image viewing and report generating tool designed to assist radiologists in the analysis of ultrasound images of breast masses by making the ACR "BI-RADS Classification Form and Lexicon® ("ABCFL") available in electronic format. The user can view any selected image from a case and segment the background by applying a user selected threshold or outlining the lesion manually with a cursor. The user can annotate, tag, measure, and record selected views. Under user control and review, the software electronically assembles reports from inputs selected by the user from the ultrasound ABCFL during the image interpretation process. The assembled report complies with the ABCFL for ultrasound. The output may be viewed and sent to electronic storage media, or standard film or paper printers or other document manipulation programs such as Adobe or Microsoft. When used by a skilled radiologist, this device provides information that may be useful in image interpretation. Paticnt management decisions should not be based solely on forms generated by BRC. The ultrasound images displayed by BRC must not be used for primary diagnostic interpretation.
    Device Description
    BI-RADS Companion™ ("BRC") is a computer-aided image viewing and report generating tool designed to assist radiologists in the analysis of ultrasound images of breast masses by making the ACR "BI-RADS Classification Form and Lexicon® ("ABCFL") available in electronic format. The user can view any selected image from a case and segment the background by applying a user selected threshold or outlining the lesion manually with a cursor. The user can annotate, tag, measure, and record selected views. Under user control and review, the software electronically assembles reports from inputs selected by the ultrasound ABCFL during the image interpretation process. The assembled report complies with the ABCFL for ultrasound. The output may be viewed and sent to electronic storage media, or standard film or paper printers or other document manipulation programs such as Adobe or Microsoft.
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