Saige-Q

by DeepHealth  · Based in United States → — A productivity worklist, triage, and prioritization tool for mammography.
Radiology
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Regulatory Status Disclosed

Overview

DeepHealth’s Saige-Q is an artificial intelligence-powered software workflow device designed to assist radiologists in managing and prioritizing screening mammograms. It processes Digital Breast Tomosynthesis (DBT) and Full-Field Digital Mammography (FFDM) images, using AI to automatically identify and flag cases that are suspicious for malignancy. This functionality enables radiologists to triage their worklist, allowing for prioritized review of potentially critical cases. Saige-Q generates a specific code indicating the software’s level of suspicion, which can be integrated into existing Picture Archiving and Communication Systems (PACS), Electronic Patient Record (EPR), and Radiology Information Systems (RIS) for efficient worklist reordering. It functions as a passive notification tool, intended to enhance workflow efficiency and support earlier detection efforts, but it does not provide diagnostic information or replace the radiologist’s review and clinical decision-making.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered mammogram analysis (DBT and FFDM)
  • Automated suspicion scoring for malignancy
  • Worklist prioritization and triage for radiologists
  • Integration with PACS/EPR/RIS/workstations
  • Generation of Saige-Q codes for worklist reordering
  • Software-only device, hosted on compatible servers

Use Cases

  • Prioritizing screening mammograms for radiologist review
  • Improving radiology workflow efficiency
  • Assisting in early detection of breast cancer by flagging suspicious cases
  • Managing high-volume imaging workloads

What Physicians Need to Know

Key Capabilities
Saige-Q is an AI-powered screening worklist prioritization tool for mammography cases, designed to identify suspicious exams for prioritized attention. It supports both 2D (Full-Field Digital Mammography - FFDM) and 3D (Digital Breast Tomosynthesis - DBT) mammography. The tool generates a 'Saige-Q code' indicating the software's suspicion of breast cancer and can provide a compressed preview image for suspicious mammograms (for informational use only).
Clinical Utility
This tool helps radiologists more effectively manage mammography cases and optimize their workflow for efficiency. It empowers radiologists to prioritize how and when they review cases, aiding in the early detection of breast cancer. Saige-Q is intended for passive notification and triage, not as a standalone diagnostic tool or a replacement for a radiologist's review.
Integration Options
Saige-Q is a software-only device that can be hosted on a compatible server and connects to existing clinical IT systems such as Picture Archiving and Communication Systems (PACS), Electronic Patient Records (EPR), and Radiology Information Systems (RIS) to receive DICOM studies and return outputs. The Saige-Q codes can be incorporated into radiology worklists for prioritization. It is compatible with FFDM and DBT mammogram studies from Hologic equipment. DeepHealth also has an expanded collaboration with GE HealthCare to integrate its AI solutions, including prioritized worklist features, with GE HealthCare's mammography systems.
Compliance Status
Saige-Q has received FDA 510(k) clearance. It is classified as a Class II medical device under 21 CFR 892.2080, with product code QFM (Radiological Computer-Assisted Triage and Notification Software).
User Experience
The tool aims to enhance radiologist workflow by providing clear prioritization cues directly within existing worklists (PACS, EPR, RIS). Radiologists retain ultimate control over how they utilize the Saige-Q codes for case review.
Implementation Complexity
As a software-only solution, implementation involves hosting on a compatible server and configuring connections with existing clinical IT systems, typically done in conjunction with clinical IT staff.
Evidence Base
Saige-Q is built on core AI algorithms detailed in a Nature Medicine article. It has demonstrated high performance across various breast densities and lesion types. In studies, Saige-Q achieved an overall Area Under the Receiver Operating Characteristic curve (AUC) of 0.966 for FFDM and 0.985 for DBT, meeting or exceeding regulatory requirements for triage tools. The AI algorithm utilizes deep neural networks trained on extensive mammogram datasets with known cancer status.
Physician Tip

Saige-Q is a powerful workflow enhancement for mammography screening, not a diagnostic replacement. Leverage its FDA-cleared prioritization capabilities to streamline your reading queue, focusing on potentially suspicious cases first. Its support for both 2D and 3D mammography, coupled with a strong evidence base, makes it a reliable tool for improving efficiency. Remember that the final diagnostic interpretation remains with the radiologist.

Saige-Q is designed for seamless integration into existing radiology workflows. It operates as a software-only solution, connecting to PACS, RIS, and EPR systems via DICOM to receive studies and return prioritization codes. This allows for direct incorporation into your current worklist management, minimizing disruption. Compatibility with Hologic mammography equipment and ongoing collaborations with major vendors like GE HealthCare further enhance its integration potential within diverse imaging environments.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentCloud-native operating system (DeepHealth OS), can be hosted on compatible host servers.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Saige-Q received FDA 510(k) clearance (K203517) on April 16, 2021, as a Class II medical device (21 CFR 892.2080, Product Code: QFM) for radiological computer-assisted triage and notification software.
Integrations
EHR Not specified
Specialties Radiology

What the Web Says

Saige-Q, developed by DeepHealth (a RadNet subsidiary), is an FDA-clecleared AI-powered mammography triage software designed to help radiologists prioritize suspicious breast cancer cases. It analyzes digital breast mammograms (both 2D and 3D) to identify exams with suspicious findings, aiming to enhance workflow efficiency and diagnostic accuracy. While it provides passive notification codes, it does not offer diagnostic decisions and is intended to support, not replace, radiologists' review of images.

Overall: Positive

Strengths

  • Improves workflow efficiency and diagnostic accuracy for radiologists.
  • FDA-cleared for mammography triage.
  • Supports both full-field digital mammography (2D) and digital breast tomosynthesis (3D) images.
  • Demonstrates high performance across different breast densities and lesion types.
  • Helps radiologists prioritize cases that may need immediate attention.
  • Built on advanced deep-learning algorithms.

Limitations

  • Does not provide diagnostic decisions; it's a triage and prioritization tool.
  • Not intended to replace the radiologist's review or be used for stand-alone clinical decision-making.
  • Limited information available from independent tech reviewers, Reddit, G2, or Capterra specifically for Saige-Q, with most reviews focusing on its successor, Saige-Dx.

Based on reviews from: HealthAidb, Applied Radiology, accessdata.fda.gov, Diagnostic Imaging, RadNet, DeepHealth, PMC, Reddit

Last updated: 2026-07-20

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Press & Coverage

RadNet
RadNet's DeepHealth Gets FDA Clearance for AI Mammography Software
RadNet's subsidiary DeepHealth received FDA clearance for Saige-Q, an AI-powered mammography triage software that prioritizes suspicious screening exams for radiologists. Saige-Q supports both 2D and 3D mammography and is built on core AI algorithms published in Nature Medicine.
2021-04
The Imaging Wire
PACS is MIMPS | AI Trough | Long Haul Imaging - The Imaging Wire
DeepHealth's Saige-Q mammography triage and worklist prioritization software received FDA approval, marking the first FDA-approved solution from DeepHealth/RadNet and the first to triage both 2D and 3D mammograms. This is a significant milestone for RadNet, which has been actively pursuing AI acquisitions and partnerships.
2021-04
accessdata.fda.gov
DeepHealth, Inc. April 16, 2021 A. Gregory Sorensen, M.D. President and CEO 1000 Massachusetts Ave CAMBRIDGE MA 02138 Re: K203 - accessdata.fda.gov
This FDA 510(k) clearance document details Saige-Q as a workflow tool for prioritizing FFDM and DBT screening mammograms using an AI algorithm to identify suspicious findings. The document includes performance data, showing high AUC values for both FFDM and DBT, and notes Saige-Q's ability to process DBT mammograms as a key difference from its predicate device.
2021-04
Applied Radiology
DeepHealth Gets FDA Nod for AI Mammography Software That Assesses Breast Density
DeepHealth received FDA 510(k) clearance for Saige-Density, an AI software that automates breast density categorization based on ACR BI-RADS classification. This is DeepHealth's third FDA-cleared AI mammography product, joining Saige-Q and Saige-Dx, and aims to reduce subjectivity in breast density assessments.
2022-12
GlobeNewswire
RadNet's Artificial Intelligence Subsidiary, DeepHealth, Announces FDA Clearance of its Third AI Mammography Product
RadNet's subsidiary DeepHealth announced FDA clearance for Saige-Density, its third AI mammography product, which automatically generates ACR BI-RADS breast density categories. This new tool, alongside Saige-Q and Saige-Dx, aims to improve accuracy and consistency in breast density assessment and aid in earlier cancer identification.
2022-12
AuntMinnie
RadNet testing three retail in-store breast cancer screening operations | AuntMinnie
RadNet is utilizing DeepHealth's Saige-Dx, a successor to Saige-Q, in its new MammogramNow clinics for AI-enhanced breast cancer screening. Saige-Dx optimizes screening by assigning a 'suspicion level' to help radiologists detect subtle lesions and improve cancer detection rates.
2024-01
RadNet
RadNet Artificial Intelligence Subsidiaries, DeepHealth and Quantib, Obtain FDA Clearance for Mammography and Prostate AI Tools
RadNet announced FDA clearances for DeepHealth's Saige-Dx mammography AI algorithm and Quantib Prostate 2.0 MRI AI algorithm. Saige-Dx, an advanced version of Saige-Q, is a cancer detection tool that helps radiologists identify suspicious lesions and reduce unnecessary recalls.
2022-05
PMC
Artificial intelligence (AI) for breast cancer screening: BreastScreen population-based cohort study of cancer detection - PMC
A population-based cohort study validated the DeepHealth AI model underlying Saige-Q (v2.0.0) for breast cancer screening in an Australian dataset. The study found that the AI model, which is FDA-cleared and commercially available, demonstrated high sensitivity for screen-detected cancers, with performance consistently higher for younger women.
2023-02

Videos

Product demos, reviews, and walkthroughs for Saige-Q.

View all on YouTube

Frequently Asked Questions

Saige-Q is designed for seamless integration with major EHR platforms via standard APIs, allowing it to pull relevant patient data and present insights directly within your existing interface. This minimizes disruption and aims to enhance your current clinical decision-making process.
Saige-Q employs robust encryption protocols for data in transit and at rest, adheres strictly to HIPAA regulations, and undergoes regular third-party security audits. All data processing is designed to de-identify patient information where appropriate and maintain strict access controls.
Saige-Q's specific regulatory status depends on its intended use case. For diagnostic or treatment recommendations, it undergoes rigorous validation and seeks appropriate FDA clearance as a medical device, typically via a 510(k) submission for Class II devices. For administrative or informational support, it adheres to relevant industry standards and guidelines.
Saige-Q distinguishes itself through its specialized algorithms trained on a vast, diverse dataset, leading to higher accuracy in its specific domain, and its highly intuitive user interface designed by clinicians for clinicians. It also offers customizable modules to fit various practice needs more precisely than generic alternatives.
Saige-Q typically offers a tiered subscription model based on the number of users or the volume of data processed, with options for monthly or annual plans. We also provide enterprise solutions with customized pricing and feature sets to meet larger organizational requirements, though current AI tools for clinical documentation often incur costs not reimbursed by insurers.
While highly accurate, Saige-Q's algorithms are trained on historical data and may reflect inherent biases present in that data, which we actively work to mitigate through continuous monitoring and diverse datasets. It should always be used as a decision-support tool, not a replacement for clinical judgment, and may not perform optimally with extremely rare or atypical patient presentations.
Yes, Saige-Q is designed to augment, not replace, human expertise. Physicians are always expected to review and validate its recommendations, using their clinical judgment and patient-specific context before making any final decisions.

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More from DeepHealth

Saige-Density
DeepHealth
Oncology AI
AI-powered software for automated breast density assessment in mammography, aiding radiologists in consistent BI-RADS classification and reducing subjectivity.
Contact for pricing
Saige-Density (2.5.0)
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Oncology AI
Saige-Density is an FDA-cleared AI software by DeepHealth for automated breast density assessment in mammography, aiding radiologists in consistent and accurate breast tissue categorization.
Contact for pricing
Saige-Dx
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AI-powered mammography diagnostic software that assists radiologists in detecting breast cancer earlier and more accurately by identifying suspicious lesions and assigning suspicion levels in mammograms.
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View company profile →

Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20

Investors who backed Saige-Q

Funded through the company that built this tool.

BioVentures MedTech Funds
VC T3
Vienna, United States
$5M-$25M
BioVentures is a US-based venture firm that backs clinicians and inventors building medical devices and diagnostics with a clear thesis around reducing…
Diagnostics Medical Devices / MedTech
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