Transpara Density

JSON twin: https://www.healthaidb.com/software/transpara-density.json

Company Name

Screenpoint Medical

Product URL

https://www.screenpointmedical.com/transpara-density

Company URL

https://www.screenpointmedical.com

Categories

• clinical Care
• diagnostic Support
• administrative Operations
• Clinical
• Diagnostic
• Administrative

Summary

Transpara Density is an AI-driven tool by ScreenPoint Medical that automates breast density assessment in mammograms, enhancing breast cancer detection and risk evaluation.

Description

Transpara Density is part of the Transpara Breast AI Suite, designed to automate volumetric and BI-RADS-like breast density assessments for both 2D and 3D mammograms. It integrates with existing radiology workflows, providing a clear, concise, and accurate evaluation of mammograms to assist radiologists in prioritizing high-risk cases and reducing reading time. The tool is CE marked and FDA cleared, ensuring its safety and efficacy in clinical settings. Transpara Density is compatible with various mammography systems from major vendors, including Hologic, GE, Siemens, Fuji, and Philips. It has been evaluated in over 35 peer-reviewed studies, demonstrating its effectiveness in improving breast cancer detection and reducing recall rates. The tool is available in more than 30 countries and supports multiple languages, catering to a global user base. Transpara Density operates on a subscription-based pricing model, with details available upon request from ScreenPoint Medical. The company was founded in 2018 and has offices in the Netherlands and the United States.

Api Available

yes

Certifications

• FDA 510(k) K241831
• CE mark (0344)

Company Founding

2018

Company Offices

• Netherlands
• United States

Compliance

• HIPAA
• GDPR
• CE (EU medical device)
• FDA 510(k) cleared

Customers

Data Residency

US and EU hosting options; on‑prem deployments for customer region control

Data Standards

• DICOM
• HL7 v2
• FHIR
• SNOMED
• ICD-10

Deployment Model

• on_prem
• cloud
• hybrid

Features

• AI detection and marking of suspicious lesions on 2D FFDM and 3D DBT
• Exam-level cancer risk / triage score
• Lesion-level heatmaps and overlays in reader hanging protocols
• Automated density assessment (Transpara Density)
• Prioritization/triage of worklists to surface high‑risk studies
• Integration into existing PACS viewer context (no separate UI)
• Reader-specific configurable scoring/hanging preferences
• Batch processing and background analysis of mammography exams
• Quality assurance metrics and performance monitoring
• Clinical decision support for screening workflows
• Support for both screening and diagnostic mammography workflows
• Study-level reporting flags/annotations ingestible by RIS/PACS

Id

SW0283

Integration Partners

Integrations

• PACS (generic DICOM PACS vendors)
• Sectra
• Ikonopedia
• Aidoc
• Agfa
• GE Healthcare
• Fujifilm
• LifeVoxel
• RIS
• EMR/EHR (Epic/Cerner - via integrations)

Languages Supported

• English
• Dutch
• German
• French
• Italian
• Spanish
• Portuguese
• Chinese
• Japanese
• Korean
• Arabic
• Russian
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Gujarati
• Malayalam

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• DBT / tomosynthesis advanced support
• Enterprise integration connectors (PACS/RIS/EHR adapters)
• Analytics / reporting module
• Cloud-managed deployment / managed service

Os Platforms

• Web
• Windows
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Patient data anonymization/deidentification options
• Data minimization controls
• Consent management support (via integrations)

Product Code

SW0283

Product Name

Transpara Density

Ratings

Regions Available

• United States
• Netherlands
• Germany
• United Kingdom
• France
• Italy
• Spain
• Canada
• Australia
• Japan
• South Korea
• China
• India
• Brazil
• Mexico
• South Africa
• Russia
• Saudi Arabia
• United Arab Emirates
• Singapore
• Malaysia

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• TLS encrypted transport
• Role‑based access control (RBAC)
• Audit logging
• SSO/SAML support
• Two‑factor authentication (2FA)

Specialties

• Radiology
• Oncology
• Medical Imaging

Support Channels

System Requirements

On‑prem virtual appliance or server; Intel x86 CPU; NVIDIA GPU support for acceleration; Linux VM supported; DICOM‑compatible PACS and network connectivity

Target Users

• radiologists
• clinicians
• medical imaging professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Transpara Density",
  "company_name": "Screenpoint Medical",
  "product_url": "https://www.screenpointmedical.com/transpara-density",
  "company_url": "https://www.screenpointmedical.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0283",
  "summary": "Transpara Density is an AI-driven tool by ScreenPoint Medical that automates breast density assessment in mammograms, enhancing breast cancer detection and risk evaluation.",
  "description": "Transpara Density is part of the Transpara Breast AI Suite, designed to automate volumetric and BI-RADS-like breast density assessments for both 2D and 3D mammograms. It integrates with existing radiology workflows, providing a clear, concise, and accurate evaluation of mammograms to assist radiologists in prioritizing high-risk cases and reducing reading time. The tool is CE marked and FDA cleared, ensuring its safety and efficacy in clinical settings. Transpara Density is compatible with various mammography systems from major vendors, including Hologic, GE, Siemens, Fuji, and Philips. It has been evaluated in over 35 peer-reviewed studies, demonstrating its effectiveness in improving breast cancer detection and reducing recall rates. The tool is available in more than 30 countries and supports multiple languages, catering to a global user base. Transpara Density operates on a subscription-based pricing model, with details available upon request from ScreenPoint Medical. The company was founded in 2018 and has offices in the Netherlands and the United States.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "administrative Operations",
    "Clinical",
    "Diagnostic",
    "Administrative"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "radiologists",
    "clinicians",
    "medical imaging professionals"
  ],
  "specialties": [
    "Radiology",
    "Oncology",
    "Medical Imaging"
  ],
  "regions_available": [
    "United States",
    "Netherlands",
    "Germany",
    "United Kingdom",
    "France",
    "Italy",
    "Spain",
    "Canada",
    "Australia",
    "Japan",
    "South Korea",
    "China",
    "India",
    "Brazil",
    "Mexico",
    "South Africa",
    "Russia",
    "Saudi Arabia",
    "United Arab Emirates",
    "Singapore",
    "Malaysia"
  ],
  "languages_supported": [
    "English",
    "Dutch",
    "German",
    "French",
    "Italian",
    "Spanish",
    "Portuguese",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Russian",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Telugu",
    "Marathi",
    "Tamil",
    "Gujarati",
    "Malayalam"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "Netherlands",
    "United States"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "on_prem",
    "cloud",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "Windows",
    "Linux"
  ],
  "features": [
    "AI detection and marking of suspicious lesions on 2D FFDM and 3D DBT",
    "Exam-level cancer risk / triage score",
    "Lesion-level heatmaps and overlays in reader hanging protocols",
    "Automated density assessment (Transpara Density)",
    "Prioritization/triage of worklists to surface high‑risk studies",
    "Integration into existing PACS viewer context (no separate UI)",
    "Reader-specific configurable scoring/hanging preferences",
    "Batch processing and background analysis of mammography exams",
    "Quality assurance metrics and performance monitoring",
    "Clinical decision support for screening workflows",
    "Support for both screening and diagnostic mammography workflows",
    "Study-level reporting flags/annotations ingestible by RIS/PACS"
  ],
  "optional_modules": [
    "DBT / tomosynthesis advanced support",
    "Enterprise integration connectors (PACS/RIS/EHR adapters)",
    "Analytics / reporting module",
    "Cloud-managed deployment / managed service"
  ],
  "integrations": [
    "PACS (generic DICOM PACS vendors)",
    "Sectra",
    "Ikonopedia",
    "Aidoc",
    "Agfa",
    "GE Healthcare",
    "Fujifilm",
    "LifeVoxel",
    "RIS",
    "EMR/EHR (Epic/Cerner - via integrations)"
  ],
  "data_standards": [
    "DICOM",
    "HL7 v2",
    "FHIR",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": "On‑prem virtual appliance or server; Intel x86 CPU; NVIDIA GPU support for acceleration; Linux VM supported; DICOM‑compatible PACS and network connectivity",
  "compliance": [
    "HIPAA",
    "GDPR",
    "CE (EU medical device)",
    "FDA 510(k) cleared"
  ],
  "certifications": [
    "FDA 510(k) K241831",
    "CE mark (0344)"
  ],
  "security_features": [
    "TLS encrypted transport",
    "Role‑based access control (RBAC)",
    "Audit logging",
    "SSO/SAML support",
    "Two‑factor authentication (2FA)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Patient data anonymization/deidentification options",
    "Data minimization controls",
    "Consent management support (via integrations)"
  ],
  "data_residency": "US and EU hosting options; on‑prem deployments for customer region control",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0283",
  "slug": "transpara-density",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/transpara-density.json"
  }
}