Medical Imaging AI
Lunit Vendor Risk Profile
Lunit is a medical AI software company specializing in deep learning-based image analytics for cancer diagnostics, providing tools for breast cancer detection and chest X-ray triage.
Risk Score
/100
AI Trust
/100
Compliance Overview
HIPAA Compatible
Conditional
BAA Available
Yes
Hosting Model
—
Healthcare Focused
Yes
Approval Status
Approved With Restrictions
Risk Level
Elevated Risk
Last Reviewed
2026-08-18
Last Verified
September 30, 2026
Review Frequency
Quarterly
Verification reflects VNDRIQ's latest automated source check. Editorial review is a separate human assessment.
AI & Data Policies
AI Training Policy
Deep learning models are trained on large-scale, biopsy-proven databases including over 240,000 mammography cases and 160,000 chest images.
Data Retention Policy
Review Required
Support Access Risk
—
Approved Use Cases
Adjunctive computer-assisted detection and diagnosis (CADe/x) for breast cancer in mammography and prioritization/triage of urgent findings in chest X-rays.
Restricted Use Cases
Intended for use as an adjunctive tool by interpreting physicians after an initial read; not a replacement for clinical judgment or complete clinician review.
Deployment & Data Residency
Deployment Type
Cloud / On-Premise
Model Type
—
Deployment Environment
—
Hosting Regions
—
Available Regions
—
Data Residency
—
Customer Data Residency Options
—
Cross-Border Data Transfer
—
Data Residency Controls
—
Security & Compliance
SOC 2
Review Required
ISO 27001
Review Required
ISO 42001
—
HIPAA Documentation
https://www.lunit.io/wp-content/uploads/2026/05/Online-BAA-May-2026-1.pdf
Encryption
Standard DICOM encryption (TLS/AES) for PACS and storage integration.
SSO
Review Required
MFA
Review Required
Private Networking
—
Private Endpoints
—
Subprocessors
—
Incident Notifications
—
Security Whitepaper
—
Executive Summary
Primary Use Cases
Key Procurement Considerations
Security Highlights
Vendor Trust Score
Limited Trust Data
11
/100
Informational framework based on publicly available and registry data. Not a certification or guarantee. Asterisks indicate categories with limited registry data.
Security & Compliance Dashboard
Standardized view of available registry security information. Not Verified indicates the registry has no documented data.
AI Governance Maturity
Minimal governance documentation; early-stage controls.
Assessed Indicators
Procurement Risk Considerations
Informational considerations for procurement evaluation, not definitive ratings.
Governance Maturity
Foundational
Security Readiness
33/100 security controls
Compliance Readiness
0/100 compliance documentation
Integration Complexity
API not verified — verify integration path
Operational Complexity
Not Verified
Vendor Transparency
0/100 transparency
Healthcare Experience
Healthcare focus not verified
Documentation Completeness
0/100 governance docs
Vendor Lifecycle & Change History
Available registry milestones. Detailed change tracking expands as the registry matures.
Profile Updated
2026-09-30
Last Website Review
2026-09-30
Last Verification
2026-09-30
Last Registry Review
2026-08-18
Registry Added
2026-08-18
Regulated Use Assessment
Healthcare
Healthcare Focused
Yes
HIPAA Compatibility
Conditional
BAA Availability
Yes
Financial Services
SOC 2
Review Required
ISO 27001
Review Required
VNDRIQ does not classify vendors as HIPAA Compliant, SEC Compliant, or FINRA Approved unless official evidence exists. Vendor suitability depends on each organization's governance requirements, contractual obligations, deployment model, risk tolerance, and applicable regulations.
Review Notes
Lunit INSIGHT MMG (K211678) and Lunit INSIGHT CXR Triage (K211733) are FDA 510(k) cleared. Lunit Insight DBT also received clearance in November 2023.
Other Medical Imaging AI Vendors
Quick Facts
Category
Medical Imaging AI
Headquarters
Seoul, South Korea
Year Founded
2013
Deployment Type
Cloud / On-Premise
Website
Risk Score
/100
AI Trust Score
/100
Last Reviewed
2026-08-18
Last Verified
September 30, 2026
Vendor Governance
Approval Tier
Approved With RestrictionsBAA Verification
Not StartedPHI Exposure
HighAI Risk Level
MediumLast Review
2026-09-30
Next Review Due
2026-11-18
Verification Status
Verified
Last Verified
2026-09-30
Next Review Date
2026-11-18
Review Frequency
Quarterly
Vendor Completeness Score
100/100
CompleteWebsite Present
Category Assigned
Approval Status Present
BAA Status Present
PHI Exposure Classified
Risk Level Present
Review Date Present
Verification Notes Present
Trust & Transparency
Last Reviewed Date
2026-08-18
Review Frequency
Quarterly
Vendor Verification Process
Every vendor is reviewed against public documentation, trust centers, and contract evidence before classification.
Editorial Independence Statement
VNDRIQ classifications are independent of vendor relationships. Ratings reflect available evidence and governance risk only.
Registry Update Policy
The registry is reviewed on a monthly cycle. All updates are editor-reviewed before publication; no automated public data changes.
Editorial Methodology
Vendors are evaluated across compliance, security, AI governance, and enterprise readiness. Each review follows a standardized 12-point checklist covering website, HIPAA, BAA, security, compliance, AI capabilities, deployment, pricing, product changes, ownership, integrations, and documentation.
Trust Signals
Vendor Benchmarking
Comparison against registry averages where supported. Benchmarks are informational and based on registry data.
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VNDRIQ vendor ratings are for operational risk screening and governance support. Final approval should include legal, compliance, security, and contract review before any PHI or regulated data is shared. Risk classifications are based on available public information and internal review at time of last verification.