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510(k) Data Aggregation

    K Number
    K202013
    Device Name
    WRDensity by Whiterabbit.ai
    Manufacturer
    Whiterabbit.ai Inc.
    Date Cleared
    2020-10-30

    (101 days)

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

    Whiterabbit.ai Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WRDensity is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. WRDensity provides an ACR BI-RADS 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. WRDensity produces adjunctive information. It is not a diagnostic aid.
    Device Description
    WRDensity is a standalone software application that automatically analyzes "for presentation" data from digital breast x-ray systems with a deep learning algorithm to assess breast tissue composition. WRDensity primarily generates two outputs for an exam, the Breast Density Level (BDL) and the Breast Density Level Probabilities (BDLP). The Breast Density Level is a categorical breast density assessment in accordance with the American College of Radiology (ACR) Breast Imaging Reporting and Data System (BI-RADS®) Atlas 5th Edition breast density categories "A" through "D". The BDL is the primary output of WRDensity. The Breast Density Level Probabilities are the probabilities calculated by WRDensity for each of the four density categories. The BDLP is a secondary output that provides more information about the breast density of an exam and the device's confidence level. WRDensity takes in images via a Digital Imaging and Communications in Medicine (DICOM) transfer from the facility's mammography imaging system, Picture Archive and Communication Server (PACS), or DICOM router. After analysis, WRDensity sends outputs to be stored in the PACS and Radiology Information System (RIS). These outputs can then be reviewed by the radiologist on the mammography workstation as a DICOM Secondary Capture Image, a DICOM Structured Report, and in the RIS. These outputs can be configured to match user preferences.
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