Transpara Density: AI Breast Density Reporting
Authorized ScreenPoint Medical Breast AI supplier. Breast density poses unique challenges in mammography and can obscure risk. Transpara Density is an AI software solution that reports breast density accurately and consistently by combining the power of two tailored algorithms, a BI-RADS-like breast density assessment and a volumetric breast density assessment. Together they reduce reader variability and help ensure compliance, consistency, and confidence.
In the United States, density reporting is now required by law under the MQSA Final Rule. Because Transpara Density reports density in parallel while reading, it adds efficiency and consistency from the start. The results are available through the systems and platforms already in use, and Transpara Density is part of the broader Transpara Breast AI suite. Transpara is CE marked and FDA cleared for 2D and 3D mammography.
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Two Density Algorithms, Reported in Parallel While Reading
Transpara Density runs two complementary algorithms on each mammogram. A BI-RADS-like composition assessment conforms to reporting standards for both 2D and 3D mammography, while a volumetric breast density assessment provides a risk-relevant measure trained on breast MRI ground truth. Both are reported in parallel during reading. Full detail is in the expandable sections below.
Standard: analyzes mammograms by BI-RADS-like breast composition categories based on the 5th edition
Modalities: available for both full field digital mammography and digital breast tomosynthesis
Repeatable assessment: offers a repeatable assessment of dense breast tissue in each mammogram
Compliance: conforms to reporting standards to help comply with the MQSA Final Rule
Volumetric breast density: a volumetric assessment available at a glance
Risk prediction: in clinical studies, volumetric breast density has been shown to be a strong predictor of the risk of developing breast cancer
Risk model: included in the IBIS Breast Cancer Evaluation Tool, also known as Tyrer-Cuzick version 8
Ground truth: trained and refined with a ground truth dataset from breast MRI
How Transpara Density compares against manual density reporting:
A single subjective density read can vary from one radiologist to another, which makes density reporting inconsistent and can obscure risk. Transpara Density pairs a BI-RADS-like composition category, which conforms to reporting standards, with a volumetric breast density measure that is a strong predictor of breast cancer risk and feeds the Tyrer-Cuzick version 8 model. Reporting both in parallel while reading reduces variability, supports MQSA compliance, and gives radiologists consistent, confident density results from the start.
Full Solution Specifications
Complete reference data for procurement, IT review, and clinical evaluation. Breast imaging directors, radiologists, and imaging IT teams rely on this capability set when they evaluate breast density AI. Expand each category for full detail.
| Solution Type | AI software for automated breast density reporting |
| Algorithm One | BI-RADS-like breast composition, 5th edition categories |
| Algorithm Two | Volumetric breast density assessment |
| Suite | Part of the Transpara Breast AI suite |
| Manufacturer | ScreenPoint Medical BV |
| Standard | BI-RADS-like breast composition categories, 5th edition |
| Modalities | Full field digital mammography and digital breast tomosynthesis |
| Output | Repeatable assessment of dense breast tissue in each mammogram |
| Purpose | Conforms to reporting standards to help comply with MQSA |
| Measure | Volumetric breast density, available at a glance |
| Clinical Role | Strong predictor of breast cancer risk in clinical studies |
| Risk Model | Included in the IBIS Breast Cancer Evaluation Tool, Tyrer-Cuzick version 8 |
| Ground Truth | Trained and refined with a ground truth dataset from breast MRI |
| Reading Workflow | Density reported in parallel while reading |
| Delivery | Available through the systems and platforms already in use |
| Transpara Detection | Validated Breast AI tool that helps radiologists find more cancer |
| Transpara Temporal Comparison | Tracks findings across up to three prior mammograms, from 9 months to 6.5 years prior |
| CE Marking | CE marked, CE 0344 certified |
| FDA Clearance | FDA cleared for 2D and 3D mammography |
| FDA 510(k) | K241831 and K232096 |
| Availability | Not all features are available in all countries |
| Manufacturer | ScreenPoint Medical BV |
Clinical Applications
Transpara Density supports breast density reporting across screening and diagnostic mammography in breast centers, radiology departments, and hospitals.
Density is reported in parallel while reading, which supports the United States MQSA Final Rule requirement for breast density reporting.
A repeatable BI-RADS-like composition assessment characterizes dense breast tissue in each mammogram.
Volumetric breast density feeds the Tyrer-Cuzick version 8 risk model as a strong predictor of breast cancer risk.
The BI-RADS-like composition assessment runs on full field digital mammography, which is 2D imaging.
The composition assessment is also available for digital breast tomosynthesis, which is 3D imaging.
AI automated assessment reduces reader variability so density reporting stays consistent across radiologists.
Density Reporting in Parallel With Reading
Transpara Density is designed to fit the existing mammography reading workflow, running both density algorithms in parallel and delivering results in the platforms already in use. The stages below outline the workflow and the wider Breast AI suite.
Transpara Density analyzes each mammogram by BI-RADS-like breast composition categories based on the 5th edition standard. It is available for both full field digital mammography and digital breast tomosynthesis and provides a repeatable assessment of dense breast tissue in each mammogram.
In parallel, a volumetric breast density assessment is available at a glance. Volumetric breast density has been shown in clinical studies to be a strong predictor of breast cancer risk and is included in the IBIS Breast Cancer Evaluation Tool, also known as Tyrer-Cuzick version 8. The algorithm was trained and refined with a ground truth dataset from breast MRI.
By having density reported in parallel while the radiologist reads the study, Transpara Density ensures enhanced efficiency and consistency from the start, and it supports the MQSA Final Rule requirement for density reporting in the United States.
The results from Transpara Density are available through the systems and platforms already in use, so the density assessment fits the current reading environment without a separate tool or step.
Transpara Density is part of the Transpara Breast AI suite. Transpara Detection is a validated Breast AI tool that helps radiologists find more cancer and enhances the reading workflow, and Transpara Temporal Comparison tracks findings across up to three prior mammograms, from 9 months to 6.5 years prior.
Regulatory Clearance and Quality
Transpara is CE marked, with CE 0344 certification, and FDA cleared for 2D and 3D mammography under FDA 510(k) numbers K241831 and K232096, and it supports the MQSA Final Rule for density reporting. Medical Outfitters is an ISO 13485:2016 certified supplier, so every order is handled through a documented and audited quality management system. Full detail is in the expandable sections below.
Transpara is CE marked, with CE 0344 certification, and FDA cleared for 2D and 3D mammography. The FDA 510(k) clearance numbers are K241831 and K232096. Not all features are available in all countries, so local availability should be confirmed with a representative.
In the United States, breast density reporting is now required by law under the MQSA Final Rule. By reporting density in parallel while reading and conforming to BI-RADS-like reporting standards, Transpara Density helps ensure consistent and compliant density reporting.
Transpara Density is developed by ScreenPoint Medical BV. ScreenPoint, Transpara, and the related brand assets are protected trademarks of ScreenPoint Medical.
Medical Outfitters Inc. is an independently ISO 13485:2016 certified supplier of medical imaging equipment. Every Transpara Density order is handled through a documented and audited quality management system.
Integration & Demo Review
Share your current mammography reading platform, PACS, and reporting systems. Our team confirms how Transpara Density delivers results within your existing workflow and can arrange a demo with the ScreenPoint team before your order is finalized.
Breast Center Procurement & Licensing
Licensing, technical documentation, and rollout planning for breast imaging AI. We support radiologists, breast imaging directors, and imaging IT teams sourcing breast density AI. Contact us for proposals.
Frequently Asked Questions
Quick answers to the most common purchase, clinical, and regulatory questions about Transpara Density. Tap any question to expand.
Transpara Density from ScreenPoint Medical is an AI software solution for automated breast density reporting on mammograms. It combines two tailored algorithms, a BI-RADS-like breast composition assessment and a volumetric breast density assessment, to reduce reader variability and help ensure compliance, consistency, and confidence. It is part of the Transpara Breast AI suite.
The first algorithm analyzes mammograms by BI-RADS-like breast composition categories based on the 5th edition standard, which conforms to reporting standards and helps with MQSA compliance. The second algorithm provides a volumetric breast density assessment, which has been shown in clinical studies to be a strong predictor of breast cancer risk. Used together, the two algorithms reduce variability and add consistency.
Yes. The BI-RADS-like composition assessment is available for both full field digital mammography, which is 2D, and digital breast tomosynthesis, which is 3D. Transpara is CE marked and FDA cleared for both 2D and 3D mammography, so it supports the common mammography workflows used in breast imaging.
In the United States, breast density reporting is now required by law under the MQSA Final Rule. Transpara Density reports density in parallel while the radiologist reads the study, which conforms to BI-RADS-like reporting standards and helps ensure consistent, compliant density reporting from the start, with enhanced efficiency.
Yes. In clinical studies, volumetric breast density has been shown to be a strong predictor of the risk of developing breast cancer, and it is included in the IBIS Breast Cancer Evaluation Tool, also known as Tyrer-Cuzick version 8. The Transpara Density volumetric algorithm was trained and refined with a ground truth dataset from breast MRI.
Yes. Transpara is CE marked, with CE 0344 certification, and FDA cleared for 2D and 3D mammography under FDA 510(k) numbers K241831 and K232096. Not all features are available in all countries, so local availability should be confirmed with a representative.
The results from Transpara Density are available through the systems and platforms already in use, and density is reported in parallel while reading. It is part of the Transpara Breast AI suite, which also includes Transpara Detection for cancer detection and Transpara Temporal Comparison, which tracks findings across up to three prior mammograms, from 9 months to 6.5 years prior.
Transpara Density is available through Medical Outfitters Inc., an ISO 13485:2016 certified supplier based in Miami, FL. We support integration and deployment with your existing mammography reading platforms. Call (305) 885-4045 or request a quote online.
Compatible Equipment
Breast imaging equipment that Transpara Density works alongside, from the digital mammography and tomosynthesis systems that acquire the mammograms it analyzes to the high resolution mammography monitor radiologists read on.
Fujifilm ASPIRE Cristalle
Digital mammography · FFDM and tomosynthesis · acquires the mammograms
View Product
LG 31HN713D Mammography Monitor
31" 12MP IPS · reads density and mammography studies · diagnostic review
View ProductRequest a Quote Today
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