Lunit INSIGHT DBT

JSON twin: https://www.healthaidb.com/software/lunit-insight-dbt.json

Company Name

Lunit

Product URL

https://www.lunit.io/products/dbt

Company URL

https://lunit.io

Categories

• diagnostic Support
• clinical Care
• radiology
• oncology Care
• Diagnostic
• Clinical
• Oncology

Summary

Lunit INSIGHT DBT is an AI-powered solution designed to enhance the detection and diagnosis of breast cancer through 3D imaging analysis.

Description

Lunit INSIGHT DBT analyzes 3D images from Digital Breast Tomosynthesis (DBT) equipment to assist radiologists in identifying suspicious lesions, providing abnormality scores, and highlighting lesion types such as soft tissue lesions and calcifications. It supports various integration types, including SR, SC, GSPS, and an In-App Viewer, and offers features like heatmaps and contours for lesion visualization. The solution has received FDA 510(k) clearance and CE marking under the EU MDR, facilitating its deployment in the U.S. and European markets.

Api Available

yes

Certifications

• FDA 510(k)
• CE mark
• ISO 13485:2016
• ISO/IEC 27001
• MDSAP

Company Founding

2013

Company Offices

• South Korea
• United States
• Netherlands
• China

Compliance

• ISO 27001
• ISO 13485
• MDSAP
• CE mark
• FDA clearance
• MFDS
• GDPR
• HIPAA

Customers

Data Residency

US/EU regions

Data Standards

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

Deployment Model

• on_prem
• cloud
• hybrid

Features

• AI detection of malignant and benign lesions on mammography
• Quantitative breast density assessment
• AI-based triage to reduce radiologist reading workload
• Lesion localization heatmaps and bounding boxes
• Per-case and per-image abnormality scoring
• Integration-ready DICOM image ingestion
• Batch processing for screening programs
• Clinical performance reports and metrics
• Support for screening and diagnostic mammography use cases
• Clinical evidence and validation studies

Id

SW0146

Integration Partners

Integrations

• Fujifilm
• GE Healthcare
• Philips
• Sectra
• Agfa
• Merative
• Infinite
• Guardant
• Emergent
• PACS
• RIS
• VNA
• Mammography vendor modalities

Languages Supported

• English
• Korean
• Chinese
• Dutch
• German
• French
• Spanish
• Italian
• Portuguese
• Japanese

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• In-App Viewer
• Storage Server (STS)

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0146

Product Name

Lunit INSIGHT DBT

Ratings

Regions Available

• United States
• European Union
• South Korea
• China
• Netherlands
• United Kingdom
• Australia
• Canada
• Japan
• India

Related Urls

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

Release Year

Security Features

• Data encryption in transit
• Data encryption at rest
• Role-based access control (RBAC)
• Audit logs
• SSO/SAML support
• Vulnerability management/bug bounty

Specialties

• Radiology
• Oncology
• Breast Imaging

Support Channels

System Requirements

Intel 2.0 GHz 6 cores or higher; 32GB RAM or higher; 256GB SSD or higher; NVIDIA GPU with Compute Capability 7.5/8.6 and 4GB VRAM or higher

Target Users

• radiologists
• clinicians
• medical imaging professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Lunit INSIGHT DBT",
  "company_name": "Lunit",
  "product_url": "https://www.lunit.io/products/dbt",
  "company_url": "https://lunit.io",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0146",
  "summary": "Lunit INSIGHT DBT is an AI-powered solution designed to enhance the detection and diagnosis of breast cancer through 3D imaging analysis.",
  "description": "Lunit INSIGHT DBT analyzes 3D images from Digital Breast Tomosynthesis (DBT) equipment to assist radiologists in identifying suspicious lesions, providing abnormality scores, and highlighting lesion types such as soft tissue lesions and calcifications. It supports various integration types, including SR, SC, GSPS, and an In-App Viewer, and offers features like heatmaps and contours for lesion visualization. The solution has received FDA 510(k) clearance and CE marking under the EU MDR, facilitating its deployment in the U.S. and European markets.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "radiology",
    "oncology Care",
    "Diagnostic",
    "Clinical",
    "Radiology",
    "Oncology"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "radiologists",
    "clinicians",
    "medical imaging professionals"
  ],
  "specialties": [
    "Radiology",
    "Oncology",
    "Breast Imaging"
  ],
  "regions_available": [
    "United States",
    "European Union",
    "South Korea",
    "China",
    "Netherlands",
    "United Kingdom",
    "Australia",
    "Canada",
    "Japan",
    "India"
  ],
  "languages_supported": [
    "English",
    "Korean",
    "Chinese",
    "Dutch",
    "German",
    "French",
    "Spanish",
    "Italian",
    "Portuguese",
    "Japanese"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "South Korea",
    "United States",
    "Netherlands",
    "China"
  ],
  "company_founding": "2013",
  "deployment_model": [
    "on_prem",
    "cloud",
    "hybrid"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "AI detection of malignant and benign lesions on mammography",
    "Quantitative breast density assessment",
    "AI-based triage to reduce radiologist reading workload",
    "Lesion localization heatmaps and bounding boxes",
    "Per-case and per-image abnormality scoring",
    "Integration-ready DICOM image ingestion",
    "Batch processing for screening programs",
    "Clinical performance reports and metrics",
    "Support for screening and diagnostic mammography use cases",
    "Clinical evidence and validation studies"
  ],
  "optional_modules": [
    "In-App Viewer",
    "Storage Server (STS)"
  ],
  "integrations": [
    "Fujifilm",
    "GE Healthcare",
    "Philips",
    "Sectra",
    "Agfa",
    "Merative",
    "Infinite",
    "Guardant",
    "Emergent",
    "PACS",
    "RIS",
    "VNA",
    "Mammography vendor modalities"
  ],
  "data_standards": [
    "DICOM",
    "HL7 v2",
    "FHIR",
    "SNOMED CT",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": "Intel 2.0 GHz 6 cores or higher; 32GB RAM or higher; 256GB SSD or higher; NVIDIA GPU with Compute Capability 7.5/8.6 and 4GB VRAM or higher",
  "compliance": [
    "ISO 27001",
    "ISO 13485",
    "MDSAP",
    "CE mark",
    "FDA clearance",
    "MFDS",
    "GDPR",
    "HIPAA"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE mark",
    "ISO 13485:2016",
    "ISO/IEC 27001",
    "MDSAP"
  ],
  "security_features": [
    "Data encryption in transit",
    "Data encryption at rest",
    "Role-based access control (RBAC)",
    "Audit logs",
    "SSO/SAML support",
    "Vulnerability management/bug bounty"
  ],
  "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": "SW0146",
  "slug": "lunit-insight-dbt",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/lunit-insight-dbt.json"
  }
}