Quantra

by HOLOGIC  · Based in United States → — Standardizing Breast Density Assessment with AI-Powered Mammography Analysis
Oncology Radiology
Website
Claim this tool
Is this the maker? Claim the company →

Contact vendor for pricing
Regulatory Status Disclosed

Overview

Quantra™ 2.2 Breast Density Assessment Software by Hologic is an advanced AI-powered solution designed for the automated analysis of mammography images. Contrary to the initial query, this tool is not for a physician directory. Instead, it serves as an adjunctive technology for radiologists, providing consistent and unbiased assessments of breast tissue density.

Utilizing machine learning and deep-learning algorithms, Quantra software analyzes both 2D and tomosynthesis mammography images to evaluate the distribution and texture of parenchymal tissue. It then categorizes breasts into one of four composition categories, aligning with the American College of Radiology (ACR) BI-RADS® Atlas 5th Edition. This automation helps to overcome the subjectivity inherent in visual assessment, thereby elevating the standard of care and standardizing reporting across radiology practices.

Quantra 2.2 is integrated with Hologic’s 3D Mammography™ systems, including the 3Dimensions™ and Selenia Dimensions® systems, and its results can be seamlessly viewed on diagnostic workstations like SecurView® and other mammography reporting systems. While it aids in the assessment of breast tissue composition and risk prediction for breast cancer, it is important to note that Quantra is not a diagnostic aid itself.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated breast density assessment
  • Machine learning and AI-powered algorithm
  • Analyzes 2D and tomosynthesis mammography images
  • Categorizes breast tissue into four BI-RADS density categories
  • Provides consistent and unbiased assessment
  • Integrates with Hologic 3D Mammography systems (e.g., 3Dimensions, Selenia Dimensions)
  • Compatible with diagnostic workstations and mammography reporting systems
  • Aids in breast cancer risk assessment
  • Facilitates patient management protocols for supplemental imaging

Use Cases

  • Routine breast cancer screenings
  • Standardizing breast density analysis in radiology practices
  • Aiding radiologists in consistent BI-RADS reporting
  • Identifying women at higher risk due to dense breasts
  • Streamlining workflow for supplemental screening

What Physicians Need to Know

Key Capabilities
Automated breast density assessment using machine learning, analyzing both 2D and tomosynthesis mammography images. Categorizes breasts into four BI-RADSu00ae breast composition categories (ACR BI-RADS Atlas 5th Edition compliant) by analyzing parenchymal tissue distribution and texture, aiming to overcome subjectivity in visual assessment and provide unbiased, reproducible results.
Clinical Utility
Standardizes breast density reporting and facilitates patient management protocols for supplemental imaging, especially for women with dense breasts who are at higher risk for cancer and for whom detection can be challenging. It aids radiologists in assessing breast tissue composition and supports compliance with state-specific density notification laws, serving as adjunctive information rather than a diagnostic aid.
Integration Options
Well-integrated into existing mammographic workflows, allowing seamless viewing of results on Hologic's SecurViewu00ae and other diagnostic workstations and mammography reporting systems. It can serve as an automatic input for risk assessment software (e.g., Tyrer-Cuzick model) and displays density scores directly on Hologic 3Dimensionsu2122 and Seleniau00ae Dimensionsu00ae systems' acquisition workstations. Quantra is part of Hologic's integrated AI solutions suite for breast health and runs on compatible Hologic systems or servers.
Compliance Status
Received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Quantra 2.2. It is compliant with ACR BI-RADSu00ae Atlas 5th Edition guidelines for breast composition categorization. United States federal law restricts this device to sale by or on the order of a physician.
Pricing Model
Specific pricing details are not publicly available, but it is described as a 'licensed option' and part of a modular suite where users 'choose u2013 and only pay for u2013 the options you need'.
User Experience
Designed to enhance workflow for technologists and radiologists by providing automated, unbiased, and reproducible breast density assessments. Results are displayed on the acquisition workstation, streamlining workflow and facilitating point-of-care patient management.
Support Quality
Hologic systems, including Quantra, are supported by a dedicated team of clinical applications and field service engineers. Full access to technical support from the solutions center is available via email or telephone.
Implementation Complexity
Considered well-integrated into existing mammographic workflows. It can be used on current Hologic digital mammography systems (Seleniau00ae Dimensionsu00ae/3Dimensionsu2122) or comparable servers. The system can eliminate the need for a separate server when results are viewed on compatible Hologic acquisition workstations. Hologic representatives are available to assist with planning for successful implementation.
Evidence Base
Supported by clinical evaluation studies for FDA approval, including a study of 230 screening examinations demonstrating high overall agreement with radiologists' assessments, comparable to inter-reader agreement. The algorithm was trained using thousands of mammographic studies with radiologist-assigned BI-RADS categories. Research highlights breast density as a significant breast cancer risk factor.
Physician Tip

Quantra 2.2 offers an objective, AI-powered assessment of breast density, aligning with ACR BI-RADS 5th Edition. This can significantly reduce inter-reader variability and streamline reporting, particularly crucial for compliance with density notification laws and guiding supplemental screening recommendations. While it's an excellent adjunctive tool, remember it's not a diagnostic aid and should complement, not replace, comprehensive radiological interpretation. Leverage its integration with acquisition workstations for immediate patient discussions regarding personalized screening pathways.

Quantra 2.2 is designed for seamless integration within the Hologic ecosystem, specifically with Seleniau00ae Dimensionsu00ae and 3Dimensionsu2122 mammography systems, and can display results on SecurViewu00ae and other diagnostic workstations. Its ability to feed into risk assessment software like the Tyrer-Cuzick model further enhances its utility. For optimal workflow, consider its compatibility with Hologic's broader AI suite, including Genius AIu2122 Detection and 3DQuorumu2122 SmartSlices, to create a comprehensive breast health solution.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact vendor for pricing — N/A
DeploymentOn-premise (server-based, integrated with Hologic mammography systems)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

Quantra™ 2.2 Breast Density Assessment Software received 510(k) clearance (K163623) from the U.S. Food and Drug Administration (FDA) on October 20, 2017. The initial Quantra system received marketing approval in 2008.
Integrations
EHR Not specified
Specialties Oncology, Radiology

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate Quantra

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

Hologic
New Evidence Backs Hologic's AI-Powered Mammography Technology for Detecting Challenging Cancers
New research presented at the Society of Breast Imaging (SBI) Symposium in April 2026 highlights the potential of Hologic's AI-driven breast cancer detection technologies, particularly in identifying invasive lobular cancers. The study found that the AI technology identified and correctly localized close to 90% of confirmed invasive lobular cancers, including some previously interpreted as negative.
2026-04
Hologic
Newly Published Data Suggests AI's Potential to Help Streamline Mammography Reviews While Maintaining High Effectiveness in Finding Cancer
New research published in The Journal of Radiology on Hologic's 3DQuorumu00ae imaging technology demonstrates AI's potential to streamline radiologists' workflows while upholding high sensitivity in detecting breast cancer. The study found no significant difference in cancer detection rates after implementing 3DQuorum, suggesting it can help radiologists work more efficiently.
2026-04
Fierce Biotech
Hologic breast cancer study bolsters use of mammogram AI - Fierce Biotech
A study published in the American Journal of Roentgenology reviewed 7,500 digital 3D mammograms using Hologic's Genius AI Detection platform, finding that the platform flagged approximately one-third of false-negative cases as suspicious and accurately identified cancer locations. The AI also picked up 90% of previously found cases by radiologists.
2025-12
PubMed (Breast Cancer (Auckl))
Evaluation of Quantra Hologic Volumetric Computerized Breast Density Software in Comparison With Manual Interpretation in a Diverse Population
This study, published in February 2018, is the first to assess the accuracy of the R2 Quantra system at breast density stratification in a North American population. It compares qualitative interpretations of breast density with quantitative measurements using Hologic's FDA-approved R2 Quantra volumetric breast density assessment tool.
2018-02
PR Newswire
Hologic Receives FDA 510(k) Clearance of Quantrau2122 2.2 Breast Density Assessment Software
Hologic announced in November 2017 that it received 510(k) clearance from the FDA for its Quantrau2122 2.2 Breast Density Assessment Software. This software uses machine learning to analyze mammography images and provide consistent breast density assessments, aligning with ACR BI-RADSu00ae Atlas 5th Edition.
2017-11
Imaging Technology News
Hologic Receives FDA 510(k) Clearance of Quantra 2.2 Breast Density Assessment Software | Imaging Technology News
Hologic Inc. received 510(k) clearance from the FDA for its Quantra 2.2 Breast Density Assessment Software, which provides consistent breast density assessments during routine breast cancer screenings. The software utilizes a machine learning algorithm to categorize breast density into four categories.
2017-11
accessdata.fda.gov
Hologic, Inc. October 20, 2017 Neil Kelly Principal Regulatory Affairs Specialist 36 Apple Ridge Road DANBURY, CT 06810 Re: K
This FDA 510(k) clearance document from October 2017 details the Quantrau2122 2.2 software application, intended for use with digital breast x-ray systems to segregate breast density into categories. The software aids radiologists in assessing breast tissue composition and is not a diagnostic aid.
2017-10
Hologic
Quantrau00ae 2.2 | Breast Density Assessment Software - Hologic
Hologic's Quantra 2.2 breast density assessment software automates breast density analysis from mammography examinations, analyzing both 2D and tomosynthesis images for tissue distribution and texture. Powered by machine learning, it categorizes breast tissue into four density categories consistent with ACR BI-RADS Atlas 5th Edition.
unknown

Videos

Product demos, reviews, and walkthroughs for Quantra.

View all on YouTube

No FAQs available yet for this tool.

Related Tools

Surgical Reality Viewer
Surgical Reality
Oncology AI
Surgical Reality offers CE- and FDA-certified AI-powered 3D medical imaging and surgical planning software that transforms CT scans into patient-specific 3D models for thoracic surgery, enhancing precision in complex lung procedures.
Cancer Copilot
Color Health
Oncology AI
Color Health's Cancer Copilot, built with OpenAI, helps oncologists and clinicians identify and order workup needs for recently diagnosed patients, aiming to speed up time to cancer treatment. This AI tool is designed to expand cancer expertise, speed decisions, and improve care, reducing a two-hour clinical task to 10 minutes with over 95% validated accuracy.
Cercare Medical Oncology Virtual Expert
Cercare Medical
Neurology AI
Cercare Medical's Oncology Virtual Expert is an AI-powered brain tumor segmentation module that provides fast, consistent, and semi-automated tumor analysis from standard MRI data, designed for on-premise deployment within existing clinical radiology workflows.
Synapse Lung Nodule AI
Fujifilm Corporation
Oncology AI
Fujifilm's Synapse Lung Nodule AI is an AI software algorithm for detecting pulmonary nodules on CT imaging, aiming to support early detection and treatment of lung cancer.
On request
RadOncAI
Informai (for RadOncAI product) / Global Network for AI in Radiation Oncology (for RadoncAI.net)
Oncology AI
RadOncAI is an AI solution by Informai designed to optimize and enhance radiation oncology workflows, improving efficiency and accuracy in treatment planning and delivery.
FAITH project (Fatigue Therapy – AI-supported Diagnosis and Therapy of Tumour-associated Fatigue Syndrome)
Fimo Health GmbH (Consortium Leader)
Mental & Behavioral Health AI
The FAITH project is developing an AI-based solution for the diagnosis and therapy of tumor-associated fatigue syndrome in cancer patients. It uses wearable sensors, a smartphone app, and artificial intelligence to provide individualized therapy recommendations and monitor mental health.

See all Oncology AI tools →

More from Hologic

Genius AI Detection
Hologic
Oncology AI
Hologic's Genius AI Detection is a deep learning-based software that assists radiologists in the early detection of breast cancer by identifying suspicious lesions in breast tomosynthesis images, reducing false positives, and optimizing workflow.
Contact for pricing
Genius AI Detection 2.0 with CC-MLO Correlation
Hologic
Oncology AI
Hologic Genius AI Detection 2.0 with CC-MLO Correlation is an FDA-cleared AI-powered software for digital breast tomosynthesis, designed to enhance breast cancer detection by identifying suspicious lesions and correlating findings across CC and MLO views, improving diagnostic accuracy and workflow efficiency for radiologists.
Contact vendor
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
Hologic
OB/GYN AI
Hologic's Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm is the first and only FDA-cleared digital cytology system, combining AI with advanced volumetric imaging to enhance cervical cancer screening, improve detection of precancerous lesions and cancer cells, and optimize laboratory workflows.
M1000 IMAGECHECKER
Hologic
Oncology AI
Hologic's M1000 ImageChecker is an FDA-cleared computer-aided detection (CAD) system that assists radiologists in identifying suspicious areas on mammograms, such as microcalcifications and masses, to aid in the early detection of breast cancer.
Not available publicly for this legacy product; contact vendor.

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
AI Tool Finder
AI-powered search. Results may not be comprehensive.