Saige-Density (2.5.0)
by DeepHealth, Inc.
· Based in United States →
— Enabling the best care by providing products that clinicians and patients can trust through rigorous science and clinical integration.
Regulatory Status Disclosed
Overview
Saige-Density (2.5.0) by DeepHealth is a Software as a Medical Device (SaMD) designed to automate the assessment of breast tissue composition. Developed for interpreting radiologists and breast imaging specialists, the tool assists in evaluating mammography exams within clinical and screening environments.
The software integrates directly into existing radiology workflows by processing DICOM files from compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. It operates in the background, analyzing 2D mammogram images (including synthetic 2D views) using deep learning algorithms. Rather than utilizing a standalone graphical user interface, Saige-Density outputs its findings directly to the PACS or mammography viewing workstation.
Notable capabilities include:
- Automatic generation of a study-level breast density category aligned with the ACR BI-RADS Atlas 5th Edition (categories A through D).
- Standardized output delivery via two DICOM objects: a Structured Report (SR) containing the case-level density category and a Secondary Capture (SC) summary report.
- Compatibility with leading enterprise imaging viewers, enabling density scores to display directly within CAD headers or image overlays.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated breast density categorization (ACR BI-RADS classification)
- Aids interpreting physicians in breast tissue assessment
- Reduces subjectivity and variability in density assessments
- Adjunctive AI software (not a diagnostic aid)
- Compatible with FFDM and DBT systems
- Trained on a diverse database of mammography images
- Part of DeepHealth's Breast Suite for enhanced workflow
- Integrates into existing breast cancer diagnostic workflows
- Provides consistent, automated density classification
- Outputs DICOM Structured Report (SR) and Secondary Capture (SC) objects
Use Cases
- Assessing breast density during mammography exams
- Supporting radiologists in accurate and consistent breast density determinations
- Facilitating earlier identification of breast cancer through improved density assessment
- Aiding compliance with national standards for breast density notification
What Physicians Need to Know
Key Capabilities
Saige-Density is an AI-powered software that automatically generates an ACR BI-RADS Atlas 5th Edition breast density category from screening and diagnostic digital mammograms (FFDM and DBT). It processes all acceptable 2D image DICOM files and produces a single study-level breast density category. The tool aims to reduce subjectivity and variability in breast density assessments.
Clinical Utility
Saige-Density assists interpreting physicians in assessing breast tissue composition and making accurate and consistent breast density determinations. This is particularly relevant as dense breast tissue can make cancer detection more difficult and increases a woman's risk of developing breast cancer. The tool provides adjunctive information and is not intended to replace a physician's review of a mammogram or be used as a diagnostic aid.
Integration Options
Saige-Density is intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. It outputs two DICOM files: a structured report and a secondary capture object containing a summary report of the results.
Compliance Status
Saige-Density (version 2.5.0) received FDA 510(k) clearance (K243705) on December 19, 2024. It is classified as a Class II software-only medical device (product code QIH) and is substantially equivalent to a legally marketed predicate device. DeepHealth's Saige-Dx also received FDA 510(k) clearance for analyzing digital breast tomosynthesis (DBT) mammograms.
Pricing Model
The pricing model for Saige-Density is not publicly disclosed.
Evidence Base
The Saige-Density AI algorithm was trained on a racially diverse database of over 166,000 images from 30,000 mammography exams across the United States. A retrospective, multicenter study demonstrated a 91.5% alignment between Saige-Density's assessment and the consensus assessment of breast density by five breast imaging specialists. Validation was performed using a retrospective study with data from different clinical sites than those used for algorithm development, ensuring no overlap between training and testing data.
Physician Tip
Saige-Density is an adjunctive tool designed to assist in breast density assessment, not replace a physician's judgment. It can help standardize breast density reporting, which is increasingly important due to state and upcoming national regulations requiring breast density notification. While the tool provides an automated ACR BI-RADS breast density category, the final interpretation and patient management decisions remain with the qualified interpreting physician.
Saige-Density is compatible with full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. It generates DICOM Structured Reports and Secondary Capture objects, which can be integrated into existing PACS systems for viewing and reporting.
Details
| Category | Oncology AI, Radiology & Imaging AI |
| Pricing | Unknown |
| API Available | Yes |
| Data Export | Unknown |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status | Cleared AI-estimated |
| Integrations | |
| EHR | Not specified |
| Specialties | Oncology, Radiology |
What the Web Says
Saige-Density (2.5.0) is an AI-powered software developed by DeepHealth, a subsidiary of RadNet, designed to assist radiologists in assessing breast density from mammograms. It automatically generates an ACR BI-RADS breast density category, aiming to reduce subjectivity and improve consistency in determinations. The software is intended as an adjunct tool to aid interpreting physicians and not to replace their own review of a mammogram.
Overall: PositiveStrengths
- Assists radiologists in making accurate and consistent breast density determinations.
- Reduces subjectivity inherent in visual analysis of breast density.
- Can play an important role in the earlier identification of cancer.
- Trained on a diverse database of images from various geographic locations and racial backgrounds.
- Improved performance for radiologists using AI in detecting early cancers and avoiding false alarms.
- Designed to fit in parallel to the standard-of-care workflow.
Limitations
- It is an adjunct tool and not intended to replace a physician's own review of a mammogram.
- Decisions should not be made solely based on analysis by Saige-Density.
- Independent proof of benefit is thin, as the main reader study came from the vendor's own employees.
- Clearance is based on retrospective, standalone data, and real-world impact on clinical workflow and diagnostic accuracy needs to be monitored.
Based on reviews from: mdedge.com, vercel.app, g2.com, deephealth.com, fda.gov, nih.gov, healthaidb.com, radnet.com, diagnosticimaging.com, auntminnie.com, healthcaredive.com, reddit.com, medaiverdict.com
Last updated: 2026-10-29
Ratings & Reviews
No reviews yet. Be the first to review this tool!
Rate Saige-Density (2.5.0)
Press & Coverage
RadNet
RadNet's Artificial Intelligence Subsidiary, DeepHealth, Announces FDA Clearance of its Third AI Mammography Product
DeepHealth, a subsidiary of RadNet, received FDA clearance for its Saige-Density™ mammography density assessment software. This AI tool automatically generates an ACR BI-RADS® breast density category, aiming to assist radiologists in making more accurate and consistent determinations and reduce subjectivity in visual analysis. This marks DeepHealth's third AI product to receive FDA clearance in less than two years.
2022-12
AuntMinnie.com
FDA clears DeepHealth's mammography software
The FDA has cleared Saige-Density, DeepHealth's AI-based mammography breast density assessment software, which automatically generates an American College of Radiology (ACR) BI-RADS breast density category to aid radiologists. This is the third FDA clearance for a DeepHealth AI product in under two years, following Saige-Q and Saige-Dx.
2022-12
Applied Radiology
DeepHealth Nets FDA Clearance of its Third AI Mammography Product
RadNet's subsidiary, DeepHealth, has received FDA clearance for its Saige-Density mammography density assessment software. This AI tool helps radiologists determine breast density scores with improved accuracy and consistency, which is crucial for early cancer identification, especially as dense breast tissue can obscure cancers in mammograms.
2023-01
Diagnostic Imaging
FDA grants 510(k) clearance for Saige-Density™ (DeepHealth/RadNet)
The FDA has granted 510(k) clearance for Saige-Density, an AI software from DeepHealth/RadNet, which provides automated categorization of breast density based on the ACR BI-RADS classification. A retrospective study showed 91.5% alignment between Saige-Density's assessment and the consensus of five breast imaging specialists.
2022-12
FDA.gov
FDA 510(k) Premarket Notification for Saige-Density (2.5.0)
The FDA's 510(k) Premarket Notification for Saige-Density (2.5.0) from DeepHealth, Inc. indicates its classification as Automated Radiological Image Processing Software under regulation number 892.2050. The document lists the applicant and correspondent as DeepHealth, Inc.
2026-10
FDA.gov
FDA 510(k) Clearance Letter for Saige-Density
The FDA issued a 510(k) clearance letter for Saige-Density (K222275) on December 16, 2022. The software is intended for use with FFDM and DBT systems to provide an ACR BI-RADS Atlas 5th Edition breast density category, serving as an aid for interpreting physicians in assessing breast tissue composition.
2022-12
Radiology Business
RadNet's DeepHealth gets FDA nod for breast density AI
The FDA has cleared Saige-Density, software that automatically assesses breast tissue density on mammography. This product, developed by DeepHealth (a RadNet AI acquisition), provides breast radiologists with ACR BI-RADS breast density classification and is the third DeepHealth AI package to gain FDA clearance in less than two years.
2022-12
Healthcare AI Ops
DeepHealth, Inc. — FDA AI Clearances
DeepHealth, Inc. has received multiple FDA AI clearances, including for Saige-Density (2.5.0) on December 19, 2024, under product code QIH. The company's portfolio includes Saige-Dx and Saige-Q triage, demonstrating a broad range of AI solutions in mammography.
2024-12
Videos
Product demos, reviews, and walkthroughs for Saige-Density (2.5.0).
Loading videos...
Frequently Asked Questions
Saige-Density (2.5.0) is an AI-powered software developed by DeepHealth that assists radiologists in assessing breast density from mammograms. It automatically generates an ACR BI-RADS® breast density category, aiming to reduce subjectivity and improve consistency in density determinations. This is important in oncology because dense breast tissue can make it harder to detect cancer on mammograms and increases a woman's risk of developing breast cancer.
Yes, Saige-Density (2.5.0) has received FDA clearance. It is classified as a Class II medical device and is intended for use by interpreting physicians qualified to read mammography exams.
While the prompt specifically asks about Saige-Density (2.5.0), DeepHealth offers other AI tools for mammography interpretation, including Saige-Q™ for productivity and triage, and Saige-Dx™ for diagnostic breast cancer screening. The FDA 510(k) clearance for Saige-Density also mentions a predicate device called Densitas densityai™.
Saige-Density is an adjunct tool and is not intended to replace a physician's own review of a mammogram. Decisions should not be made solely based on the analysis provided by Saige-Density. It provides adjunctive information and is not a diagnostic aid.
Saige-Density is designed to be used with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. It assists the radiologist by providing an automated breast density category, which can play an important role in the earlier identification of cancer, especially as FDA regulations will soon require all women nationwide to be provided density information.
Suggest an Edit → | Report an issue
| Last Verified: 2026-04-18 | First Added: 2026-04-18
Investors who backed Saige-Density (2.5.0)
Funded through the company that built this tool.
