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510(k) Data Aggregation

    K Number
    K192973
    Device Name
    densitas densityai
    Manufacturer
    Densitas, Inc.
    Date Cleared
    2020-02-19

    (118 days)

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

    Densitas, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Densitas densityai™ is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Densityai™ provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. Densitas densityai™ produces adjunctive information. It is not a diagnostic aid.
    Device Description
    Densitas densityai™ is a standalone software application that automatically analyzes "for presentation" data from digital breast x-ray systems, including digital breast tomosynthesis exams, to assess breast tissue composition. The software processes the data according to proprietary algorithms and generates a Breast Density Grade in accordance with the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) 5th edition density classification scale. Densitas densityai™ data output is packaged for viewing on a mammography workstation or PACS as a DICOM mammography Structured Report or Secondary Capture. Output may also be transmitted to a RIS. Densitas densityai™ reports are configured to provide the following data based on the BI-RADS 5th edition breast density classification grade: For each patient: DENSITAS breast density grade (BDG).
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    K Number
    K170540
    Device Name
    DM-Density
    Manufacturer
    Densitas, Inc.
    Date Cleared
    2018-02-23

    (365 days)

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

    Densitas, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DM-Density is a software application intended for use with compatible full field digital mammography systems. DM-Density calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. DM-Density provides these numerical values for each breast as well as a density category to aid interpreting physicians in the assessment of breast tissue composition. DM-Density produces adjunctive information. It is not a diagnostic aid.
    Device Description
    DM-Density is a standalone software application that automatically analyzes "for presentation" full field digital mammograms to calculate breast tissue composition. The software processes full field digital mammograms according to proprietary algorithms and generates a Breast Density Grade in accordance with the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) density classification scales. DM-Density has been validated on Hologic's Selenia Dimensions and Lorad Selenia systems. DM-Density data output is packaged for viewing on a mammography workstation or PACS as a DICOM mammography Structured Report or Secondary Capture. Output may also be transmitted to a RIS.
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