WRDensity by Whiterabbit.ai

by Whiterabbit.ai  · Based in United States → — Transforming breast cancer screening with next-gen AI. Driving clinical precision, operational efficiency, and financial value at scale.
Radiology

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Regulatory Status Disclosed

Overview

WRDensity by Whiterabbit.ai is an AI-driven breast density software designed to assist radiologists in interpreting breast density with greater accuracy and consistency. This standalone software application analyzes ‘for presentation’ data from digital breast x-ray systems, including full-field digital mammography and digital breast tomosynthesis systems, using a deep learning algorithm to assess breast tissue composition.

The primary output of WRDensity is a categorical breast density assessment in accordance with the American College of Radiology (ACR) BI-RADS Atlas 5th Edition breast density categories (A through D). It also provides Breast Density Level Probabilities (BDLP), offering more detailed information about breast density and the device’s confidence level.

WRDensity aims to create uniformity of density assessment at the practice level, delivering highly accurate breast density classification. A longitudinal study in 2022 demonstrated that WRDensity produced more consistent assessments for patients over time compared to radiologists, with 43% more consistency across multiple years. The software was trained on over 600,000 images from the Mallinckrodt Institute of Radiology. Radiologists retain full control, able to easily disagree with the product’s assessment and report breast density based on their own appraisal without additional clicks.

The tool integrates with existing radiology workflows, taking in images via DICOM transfer from mammography imaging systems, PACS, or DICOM routers, and sending outputs to be stored in PACS and RIS for review.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-driven breast density software
  • Assists radiologists in interpreting breast density
  • Creates uniformity of density assessment at the practice level
  • Delivers highly accurate breast density classification
  • Provides ACR BI-RADS Atlas 5th Edition breast density categories (A-D)
  • Generates Breast Density Level (BDL) and Breast Density Level Probabilities (BDLP)
  • Trained on over 600,000 mammography images
  • Integrates with PACS and RIS via DICOM transfer
  • Allows radiologists to override or confirm assessments
  • Demonstrates more longitudinally consistent assessments than radiologists

Use Cases

  • Automated breast density assessment in mammography screening
  • Improving consistency and standardization of breast density interpretation
  • Aiding physicians in the objective assessment of breast tissue composition
  • Supporting individualized supplemental screening recommendations for patients
  • Enhancing radiologist workflow and productivity in breast imaging
  • Reducing unnecessary callbacks and patient anxiety by improving diagnostic accuracy (indirectly)

What Physicians Need to Know

Key Capabilities
AI-driven software for highly accurate breast density classification, assisting radiologists in interpretation and creating uniformity of density assessment. It provides objective data and can assess synthetic mammography images from DBT exams. Radiologists can easily override the AI's assessment.
Clinical Utility
Enhances the accuracy and consistency of breast density assessment, which is vital for effective patient management and individualized supplemental screening recommendations. It helps identify patients who may benefit from additional imaging and aims to reduce false positives, callbacks, biopsies, and false negatives, contributing to earlier and more accurate cancer detection.
Integration Options
Designed to integrate into existing radiologist workstations. It accepts images via DICOM transfer from mammography systems, PACS, or DICOM routers, and sends outputs (DICOM Secondary Capture Image, DICOM Structured Report, RIS entries) back to PACS and RIS for review. It is also available on the ACR's AI-LAB platform.
Compliance Status
FDA-cleared (received clearance in October 2020) and is noted as the first FDA-cleared, commercial algorithm on the ACR Connect platform. It was found to be substantially equivalent to predicate devices in terms of safety, efficacy, and performance.
Pricing Model
Specific pricing details for WRDensity are not publicly available.
User Experience
Aims to streamline workflow and enhance the diagnostic process by providing critical information in a relevant context. Radiologists can easily disagree with the AI's assessment without additional clicks.
Support Quality
Details regarding specific support quality for WRDensity are not explicitly provided, though general information for similar platforms mentions customer support during business hours and training documentation.
Implementation Complexity
Designed to fit into existing radiology workflows with DICOM integration. Setup, training, and implementation are generally included for Whiterabbit's solutions.
Evidence Base
Trained on over 600,000 images from the Mallinckrodt Institute of Radiology. A 2022 longitudinal study showed 43% more consistent assessments than radiologists. Its FDA clearance was based on a pivotal study on 871 exams, demonstrating superior performance in BI-RADS classification (quadratically-weighted Cohen's kappa of 0.90). Collaborations with Washington University School of Medicine and Stanford University for research further support its efficacy.
Physician Tip

Leverage WRDensity for standardized and consistent breast density assessment, which is crucial for effective patient management and tailoring supplemental screening recommendations. Utilize the tool's objective data to quickly identify breast density levels, especially in challenging cases. Remember that the AI serves as a supporting tool, and your clinical judgment remains paramount, with the ability to easily override its assessment. Consider the benefits of WRDensity's longitudinal consistency for patients undergoing multiple screenings over time.

WRDensity is engineered for seamless integration into existing radiology workflows. It facilitates DICOM image transfer from various mammography systems, PACS, or DICOM routers, and its outputs are designed to be stored in PACS and RIS for convenient review on standard mammography workstations. Its availability on the American College of Radiology's (ACR) AI-LAB platform further underscores its interoperability within the broader radiology ecosystem.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact vendor — Contact vendor for customized pricing.
DeploymentStandalone software application, integrates with existing RIS/PACS infrastructure.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

WRDensity received 510(k) clearance from the FDA on October 30, 2020, under submission number K202013. It is classified as a Class II medical device (Regulation Number: 21 CFR 892.2050, Product Code: QIH) intended to aid interpreting physicians in the assessment of breast tissue composition by providing an ACR BI-RADS Atlas 5th Edition breast density category.

Integrations
EHR Not specified
Specialties Radiology

What the Web Says

WRDensity by Whiterabbit.ai is an AI-driven software designed to assist radiologists in consistently assessing breast density, which is a crucial risk factor for breast cancer. The software aims to improve early detection and enhance the quality of patient care by providing accurate breast density classifications. It received FDA clearance in 2020 and has been trained on a large dataset of over 600,000 images from the Mallinckrodt Institute of Radiology.

Overall: Positive

Strengths

  • Promotes consistency in breast density assessments among radiologists.
  • Aims to facilitate earlier breast cancer detection.
  • Enhances patient reassurance through improved consistency and quality of care.
  • Utilizes advanced deep learning techniques for accurate breast density classification.
  • Trained on a large and reputable dataset of over 600,000 images.
  • Radiologists can easily override the AI's assessment if they disagree.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra regarding WRDensity by Whiterabbit.ai.
  • General concerns about AI in healthcare include the need for rigorous clinical validation and the potential for propagating data-driven errors if not properly overseen.
  • Some general Reddit discussions about AI code review tools mention issues with missing nuances and generating questionable or minor issues.

Based on reviews from: Whiterabbit.ai, Indeed.com, G2, Washington University School of Medicine in St. Louis, PR Newswire, AuntMinnie, Slashdot, SecurityWeek, FirstWord HealthTech, Applied Radiology, The Scientist, Reddit

Last updated: 2026-07-19

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Press & Coverage

accessdata.fda.gov
510(k) Premarket Notification - WRDensity by Whiterabbit.ai
This regulatory document details the FDA's 510(k) premarket notification clearance for WRDensity by Whiterabbit.ai on October 30, 2020. The software is intended to provide an ACR BI-RADS Atlas 5th Edition breast density category to aid physicians in assessing breast tissue composition.
2020-10
Orthogonal
SaMD Cleared by the FDA: The Ultimate Running List
WRDensity by Whiterabbit.ai is included in a comprehensive list of Software as a Medical Device (SaMD) cleared by the FDA, with its clearance date noted as October 30, 2020, in the radiology category. This list is a work in progress, compiled from publicly available FDA reports and regulatory search tools.
2024-10
AJR (American Journal of Roentgenology)
Artificial Intelligence (AI) for Screening Mammography, From the AJR Special Series on AI Applications
This article discusses the rapid progression of AI in breast imaging, mentioning WRDensity by Whiterabbit.ai as one of the FDA-approved AI applications for breast density assessment as of December 2021. It highlights the use of such tools in providing numeric density values and BI-RADS density categories.
2024-02
PMC (PubMed Central)
Theranostics and artificial intelligence: new frontiers in personalized medicine
WRDensity by Whiterabbit.ai is cited in this review as an FDA-approved software for BI-RADS breast density classification from 2020, within the context of current and emerging AI applications in theranostics. The article explores AI's role in personalized medicine, including patient selection, tumor dosimetry, and drug discovery.
2024-03
ResearchGate
Harnessing artificial intelligence for theragnostic applications: Current landscape and future directions
This research paper lists WRDensity by Whiterabbit.ai among FDA-approved AI-based radiological software systems used in clinical oncology applications for the categorization of breast density by BI-RADS. It emphasizes the transformative potential of AI in personalized medicine by integrating therapeutic and diagnostic techniques.
2025-02
Innolitics
Command Line as a Medical Device (CLaMD)
WRDensity by Whiterabbit.ai is mentioned as an example of a software that takes input via DICOM transfer, automatically analyzes images, and sends outputs to be stored and reviewed on other systems like PACS, RIS, and mammography workstations, implying it operates as a background process without its own interactive GUI for the end-user radiologist.
2025-05
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing
This guide references WRDensity by Whiterabbit.ai in the context of ground truthing for AI/ML SaMD, specifically mentioning its use of a consensus of five expert radiologists for independent breast density assessment on a test dataset. The article discusses methodologies for establishing reliable ground truth in medical device development.
2025-09

Videos

Product demos, reviews, and walkthroughs for WRDensity by Whiterabbit.ai.

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Frequently Asked Questions

WRDensity is an AI-driven software designed to integrate seamlessly with existing full-field digital mammography and digital breast tomosynthesis systems, as well as PACS and RIS via DICOM transfer. It automatically analyzes mammography images to provide an ACR BI-RADS Atlas 5th Edition breast density category, which radiologists can then review on their workstations. Radiologists maintain the ability to easily disagree with the AI's assessment and report breast density based on their own appraisal without additional clicks.
Yes, WRDensity received FDA 510(k) clearance in October 2020. This clearance signifies that the software provides adjunctive information to aid interpreting physicians in the assessment of breast tissue composition, aligning with the ACR BI-RADS Atlas 5th Edition. As an FDA-cleared medical device, it must comply with general controls provisions, including labeling and medical device reporting requirements.
WRDensity is intended as an adjunctive tool to assist in breast density assessment and is explicitly stated as not being a diagnostic aid. While it aims to provide consistent assessments, radiologists retain the ultimate responsibility and can override the AI's output based on their clinical judgment. Further reader studies are often required to fully investigate the impact of such AI tools on radiologist behavior and overall workflows.
While WRDensity specializes in breast density assessment, the broader market for radiology AI includes platforms like CARPL.ai, which offers a vendor-neutral environment for accessing and integrating various AI applications. Other solutions, such as Solventum Fluency for Imaging and PowerScribe One, focus on AI-powered radiology reporting and workflow efficiency. Physicians should evaluate alternatives based on their specific clinical needs, desired functionalities, and integration capabilities within their existing infrastructure.
Specific pricing details for WRDensity are not publicly available in the provided search results. However, many healthcare AI solutions, including some alternatives, commonly utilize a subscription-based pricing model. These models often encompass setup, training, and ongoing support, and interested practices would typically need to contact Whiterabbit.ai directly for a detailed quote or to request a demo.
As an FDA-cleared medical device, WRDensity is subject to regulatory requirements concerning patient data security and privacy. The software integrates with existing hospital systems like PACS and RIS via DICOM transfer, which are typically secure environments for medical imaging data. While specific security protocols are not detailed in public information, adherence to healthcare data protection standards is implicit for such a product.
WRDensity's deep learning model was trained on an extensive dataset of over 600,000 mammography images, demonstrating high accuracy in breast density classification. A 2022 longitudinal study indicated that WRDensity produced more consistent breast density assessments for patients over time compared to radiologists, showing 43% greater consistency across multiple years. Additionally, studies suggest its potential to reduce false positives in screening mammography without compromising cancer detection rates.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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