VinDr-Mammo

JSON twin: https://www.healthaidb.com/software/vindr-mammo.json

Company Name

VinBigdata

Product URL

https://vinbigdata.com/xu-ly-anh-y-te/vindr-ai-ho-tro-chan-doan-som-nhieu-benh-ly-nguy-hiem-cua-nguoi-viet.html

Company URL

https://vinbigdata.com

Categories

• diagnostic Support
• clinical Care
• radiology
• ai Clinical Documentation Integrity
• imaging Software
• Diagnostic
• Clinical
• Ai-powered
• Medical Imaging

Summary

VinDr-Mammo is an AI-powered software developed by VinBigdata to assist radiologists in prioritizing mammogram exams by identifying potentially suspicious findings, thereby enhancing workflow efficiency and expediting patient care.

Description

VinDr-Mammo is a software-as-a-medical-device (SaMD) that analyzes 2D full-field digital mammograms using machine learning algorithms to detect exam-level suspicious findings. It integrates with Picture Archiving and Communication Systems (PACS) to alert radiologists, facilitating prioritized review of critical cases. The software operates as a passive notification tool, ensuring it does not replace the physician's final diagnosis. It was approved by the FDA on May 23, 2024, under the 510(k) number K233108, and is intended for use with validated full-field digital mammography systems. Performance validation demonstrated high sensitivity (~90%), specificity (~91%), and an area under the curve (AUC) of approximately 0.96, consistent across various breast densities, age groups, scanner models, and lesion types. The average processing time per mammogram is 2.8 minutes, aligning with clinical workflow requirements. Notably, VinDr-Mammo is substantially equivalent to its predicate device, CogNet QmTRIAGE (K220080).

Api Available

unknown

Certifications

• FDA 510(k)

Company Founding

2018

Company Offices

• Vietnam
• United States

Compliance

• HIPAA
• GDPR
• FDA 510(k)

Customers

Data Residency

US/EU regions

Data Standards

• DICOM
• HL7
• FHIR

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automated diagnostics
• AI-based lesion localization
• Real-time analysis
• Multi-point consultation support
• Simultaneous diagnosis of multiple scans
• Flexible scalability

Id

SW0211

Integration Partners

Integrations

• PACS systems
• RIS systems
• Cloud storage solutions

Languages Supported

• English
• Vietnamese

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• VinDr CAD
• VinDr PACS
• VinDr-SpineXR
• VinDr-BrainCT
• VinDr-BrainMRI

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0211

Product Name

VinDr-Mammo

Ratings

Regions Available

• United States
• Vietnam

Related Urls

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

Release Year

Security Features

• Encryption
• RBAC
• Audit logs
• 2FA

Specialties

• Radiology
• Oncology
• Breast Imaging

Support Channels

System Requirements

N/A

Target Users

• radiologists
• clinicians
• medical imaging professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "VinDr-Mammo",
  "company_name": "VinBigdata",
  "product_url": "https://vinbigdata.com/xu-ly-anh-y-te/vindr-ai-ho-tro-chan-doan-som-nhieu-benh-ly-nguy-hiem-cua-nguoi-viet.html",
  "company_url": "https://vinbigdata.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0211",
  "summary": "VinDr-Mammo is an AI-powered software developed by VinBigdata to assist radiologists in prioritizing mammogram exams by identifying potentially suspicious findings, thereby enhancing workflow efficiency and expediting patient care.",
  "description": "VinDr-Mammo is a software-as-a-medical-device (SaMD) that analyzes 2D full-field digital mammograms using machine learning algorithms to detect exam-level suspicious findings. It integrates with Picture Archiving and Communication Systems (PACS) to alert radiologists, facilitating prioritized review of critical cases. The software operates as a passive notification tool, ensuring it does not replace the physician's final diagnosis. It was approved by the FDA on May 23, 2024, under the 510(k) number K233108, and is intended for use with validated full-field digital mammography systems. Performance validation demonstrated high sensitivity (~90%), specificity (~91%), and an area under the curve (AUC) of approximately 0.96, consistent across various breast densities, age groups, scanner models, and lesion types. The average processing time per mammogram is 2.8 minutes, aligning with clinical workflow requirements. Notably, VinDr-Mammo is substantially equivalent to its predicate device, CogNet QmTRIAGE (K220080).",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "radiology",
    "ai Clinical Documentation Integrity",
    "imaging Software",
    "Diagnostic",
    "Clinical",
    "Radiology",
    "Ai-powered",
    "Medical Imaging"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "radiologists",
    "clinicians",
    "medical imaging professionals"
  ],
  "specialties": [
    "Radiology",
    "Oncology",
    "Breast Imaging"
  ],
  "regions_available": [
    "United States",
    "Vietnam"
  ],
  "languages_supported": [
    "English",
    "Vietnamese"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "Vietnam",
    "United States"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Automated diagnostics",
    "AI-based lesion localization",
    "Real-time analysis",
    "Multi-point consultation support",
    "Simultaneous diagnosis of multiple scans",
    "Flexible scalability"
  ],
  "optional_modules": [
    "VinDr CAD",
    "VinDr PACS",
    "VinDr-SpineXR",
    "VinDr-BrainCT",
    "VinDr-BrainMRI"
  ],
  "integrations": [
    "PACS systems",
    "RIS systems",
    "Cloud storage solutions"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR"
  ],
  "api_available": "unknown",
  "system_requirements": "N/A",
  "compliance": [
    "HIPAA",
    "GDPR",
    "FDA 510(k)"
  ],
  "certifications": [
    "FDA 510(k)"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "Audit logs",
    "2FA"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0211",
  "slug": "vindr-mammo",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/vindr-mammo.json"
  }
}