Saige-Density

by DeepHealth (a subsidiary of RadNet, Inc.)  · Based in United States → — Automated categorization of breast density based on the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) classification.
Oncology Radiology
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Regulatory Status Disclosed

Overview

Saige-Density is an adjunctive artificial intelligence (AI) software developed by DeepHealth, a subsidiary of RadNet, Inc. It is designed to provide automated categorization of breast density based on the American College of Radiology’s (ACR) Breast Imaging Reporting and Data System (BI-RADS) classification. This tool assists interpreting physicians in making accurate and consistent determinations of breast tissue composition, thereby reducing subjectivity and variability in breast density assessments. Saige-Density is intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. It functions as an adjunct tool and is not intended to be a diagnostic aid or to replace a physician’s own review of a mammogram.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated categorization of breast density (ACR BI-RADS classification)
  • Reduces subjectivity and variability in breast density assessments
  • Aids interpreting physicians in making accurate and consistent determinations
  • Compatible with full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems
  • Functions as an adjunctive tool, not a diagnostic aid
  • Trained on a racially diverse database of over 166,000 images from 30,000 mammography exams
  • Demonstrated 91.5% alignment with consensus assessment by five breast imaging specialists in a retrospective study

Use Cases

  • Automated breast density assessment during mammography exams
  • Assisting radiologists in consistent breast density determinations
  • Supporting compliance with national standards requiring breast density notification in mammography reports
  • Improving accuracy and consistency in breast density scoring for earlier identification of cancer

What Physicians Need to Know

Key Capabilities
Saige-Density is an AI-based breast density assessment tool that automatically generates an American College of Radiology (ACR) BI-RADS breast density category. It processes screening and diagnostic digital mammograms using deep learning techniques. The software is designed to aid interpreting physicians in assessing breast tissue composition.
Clinical Utility
The tool assists radiologists in making accurate and consistent breast density determinations, helping to reduce the subjectivity inherent in visual analysis. This improved accuracy and consistency can play a role in the earlier identification of cancer, especially since dense breast tissue can make cancer detection more difficult. It provides adjunctive information and is not intended to replace a physician's own review of a mammogram.
Integration Options
Saige-Density is intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. It outputs DICOM Structured Report and Secondary Capture formats for seamless integration into clinical workflows.
Compliance Status
Saige-Density received FDA 510(k) clearance on December 16, 2022.
Pricing Model
The pricing model for Saige-Density is subscription-based; however, specific pricing details are not publicly available and require contacting the vendor.
User Experience
While specific user experience details for Saige-Density are not extensively detailed, DeepHealth's related product, Saige-Dx, has received positive feedback for its intuitive user interface and seamless integration, suggesting a similar approach for Saige-Density.
Support Quality
User reviews for DeepHealth's Saige-Dx indicate that the support team is responsive and helpful throughout implementation, and users appreciate continuous updates and improvements.
Implementation Complexity
The integration of DeepHealth products with existing systems has been described as seamless.
Evidence Base
A retrospective, multicenter study demonstrated a 91.5% alignment between Saige-Density assessments and the consensus of five breast imaging specialists. The AI algorithm was trained on a racially diverse database of over 166,000 images from 30,000 mammography exams across the United States. A multi-site retrospective study evaluated its standalone performance on DBT and FFDM mammograms, comparing its density category outputs to a consensus of five expert radiologists across 796 mammogram cases.
Physician Tip

Saige-Density serves as an adjunctive tool to assist in breast density assessment, providing an automated ACR BI-RADS breast density category. It can enhance consistency and accuracy in density determinations, which is particularly important given the challenges dense breast tissue poses for cancer detection. However, it is crucial to remember that Saige-Density is not a diagnostic aid and should not replace a physician's independent review and clinical judgment. Integrate its output as an additional data point in your comprehensive evaluation of mammograms.

Saige-Density is designed for compatibility with existing full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. It produces DICOM Structured Reports and Secondary Capture objects, facilitating integration into standard radiology workflows and PACS systems. This allows for a streamlined workflow where the AI-generated density assessment can be readily accessed alongside the mammography images.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Unknown
Compliance
BAA AvailableUnknown
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

Saige-Density, developed by DeepHealth (a subsidiary of RadNet), is an AI-powered software designed to automatically categorize breast density based on the American College of Radiology's (ACR) BI-RADS classification. It functions as an adjunctive tool to assist physicians in making accurate and consistent breast density determinations, aiming to reduce subjectivity and variability in assessments. The software has received FDA 510(k) clearance and is intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems.

Overall: Mixed

Strengths

  • Automated categorization of breast density reduces subjectivity and variability in assessments.
  • Aids interpreting physicians in making accurate and consistent determinations of breast tissue composition.
  • Compatible with full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems.
  • Demonstrated high alignment (91.5%) with consensus assessments by breast imaging specialists in a retrospective study.
  • Helps healthcare providers meet state laws and upcoming FDA requirements for breast density notification.
  • Trained on a racially diverse database of over 166,000 images from 30,000 mammography exams.

Limitations

  • It is an assistive tool and not a replacement for clinical judgment or a standalone diagnostic aid.
  • Lacks its own direct user interface for image review, relying on integration with existing PACS or viewing workstations.
  • May lead to a slight increase in recall rates, though balanced by increased cancer detection.
  • Specific physician reviews outside of study contexts are not widely published.
  • No reviews found on G2, Capterra, or Reddit.
  • Independent proof of benefit is considered thin, as the main reader study came from the vendor's own employees.

Based on reviews from: computerreview.com, nih.gov, physicianaitools.com, medaiverdict.com, radnet.com, fda.gov, auntminnie.com, stocktitan.net, parikhradiology.com, innolitics.com

Last updated: 2026-10-29

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Press & Coverage

radnet.com
RadNet's Artificial Intelligence Subsidiary, DeepHealth, Announces FDA Clearance of its Third AI Mammography Product
RadNet, Inc. announced that its subsidiary DeepHealth, Inc. received FDA clearance for its mammography density assessment software, Saige-Density™. This tool automatically generates an ACR BI-RADS® breast density category, aiding radiologists in accurate and consistent determinations using AI.
2022-12
appliedradiology.com
DeepHealth Nets FDA Clearance of its Third AI Mammography Product
DeepHealth's Saige-Density, an AI-powered breast density assessment tool, received FDA clearance, making it the company's third AI mammography product to do so in under two years. The software helps radiologists determine breast density scores with improved accuracy and consistency.
2023-01
auntminnie.com
FDA clears DeepHealth's mammography software
The U.S. Food and Drug Administration (FDA) has cleared RadNet subsidiary DeepHealth's Saige-Density mammography breast density assessment software. Saige-Density is an AI-based tool that automatically generates an American College of Radiology (ACR) BI-RADS breast density category.
2022-12
radiologybusiness.com
FDA clears DeepHealth's Saige-Density for automated breast density assessment
The FDA has cleared Saige-Density, a software from DeepHealth that automatically assesses breast tissue density on mammography, providing breast radiologists with ACR BI-RADS breast density classification. This marks DeepHealth's third AI product to gain FDA clearance in less than two years.
2022-12
fda.gov
510(k) Premarket Notification K222275
The FDA granted 510(k) clearance for Saige-Density on December 16, 2022. Saige-Density is a software as a medical device that processes screening and diagnostic digital mammograms using deep learning techniques to aid in assessing breast density.
2022-12
innolitics.com
DeepHealth, Inc. Saige-Density (2.5.0)
DeepHealth, Inc.'s Saige-Density (version 2.5.0) outputs DICOM files (structured and secondary capture reports) that can be viewed on a mammography workstation, implying the software itself does not provide the primary viewing interface.
2025-05
medaiverdict.com
DeepHealth: The radiology AI arm of RadNet
DeepHealth, a subsidiary of RadNet, has ten FDA records under its name for various breast screening tools, including Saige-Density. It aims to provide a broad portfolio of AI solutions for mammography, prostate, lung, brain, bone, and chest X-ray software.
2026-10
radmagazine.com
DeepHealth's AI-Powered Solutions for Breast Cancer Screening and Radiology Workflow Optimization
DeepHealth, a RadNet subsidiary, develops AI-powered software for breast cancer screening and radiology workflow optimization, with Saige-Density being one of its flagship tools for automated breast density assessment. Its solutions are deployed across over 800 clinical sites and used by more than 3,000 radiologists globally.
2026-02

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Frequently Asked Questions

Saige-Density is a software application that processes screening and diagnostic digital mammograms using deep learning to provide an ACR BI-RADS Atlas 5th Edition breast density category. This tool assists interpreting physicians in assessing breast tissue composition, aiming to reduce the subjectivity inherent in visual analysis and improve the accuracy and consistency of density determinations. This can be particularly important for the earlier identification of cancer, as dense breast tissue can obscure cancers on mammograms and increases a woman's risk of developing breast cancer.
Saige-Density is a Software as a Medical Device that has received FDA 510(k) clearance. It is intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. The software is an adjunctive tool and not a diagnostic aid, meaning it is not intended to replace a physician's own review of a mammogram, and decisions should not be made solely based on its analysis.
Yes, there are other AI applications for breast density assessment available. Beyond AI, alternative methods to measure breast density include Optical Breast Spectroscopy (OBS) and Dual X-ray Absorptiometry (DXA), particularly for younger women. For breast cancer screening in general, alternatives or complements to mammography include ultrasounds and MRIs, especially for patients with dense breasts or higher risk factors.
Saige-Density is an adjunct tool and not a diagnostic aid, meaning it should not replace a physician's judgment or be the sole basis for decisions. More broadly, AI systems in oncology can have limitations such as insufficient accuracy, limited data diversity leading to bias in certain patient populations, and a lack of transparency in their decision-making processes, often referred to as 'black box' behavior.
Saige-Density is designed to integrate into standard-of-care workflows. It processes acceptable 2D image DICOM files (FFDM and/or 2D synthetics) and generates a single study-level breast density category. The software outputs two DICOM files: a structured report and a secondary capture, which can be overlaid on original mammogram images using a standard viewing workstation.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
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