Medihub Prostate

JSON twin: https://www.healthaidb.com/software/medihub-prostate.json

Company Name

JLK

Product URL

https://www.jlkinc.com/medihub-prostate

Company URL

https://www.jlkinc.com

Categories

• diagnostic Support
• clinical Care
• radiology
• oncology Care
• imaging Software
• clinical Decision Support
• Diagnostic
• Clinical
• Oncology
• Ai-based Imaging Analysis

Summary

Medihub Prostate is an AI-driven software developed by JLK Inc. to assist in diagnosing prostate cancer by analyzing MRI images and PSA levels.

Description

Medihub Prostate is an AI-based diagnostic solution that analyzes prostate MRI images and assesses prostate-specific antigen (PSA) levels to aid in the detection of prostate cancer. Developed by JLK Inc. in collaboration with Seoul Asan Medical Center and the University of Missouri, it received FDA 510(k) clearance on June 21, 2024. The software semi-automatically outlines the prostate region in MRI images, requiring user editing and confirmation, and provides multiparametric MRI viewing and combined image visualization. It is intended for use by trained radiologists and urologists to support clinical decision-making without replacing expert judgment. The device has been validated for use with Siemens 3T Vida and Skyra MRI machines and is designed for patients aged 55 years and above. The software is accessible via a web browser and integrates multiple MRI sequences into single images, outputting structured reports including PI-RADS scores. Medihub Prostate has also secured a domestic technology patent in South Korea, further validating its technological excellence.

Api Available

unknown

Certifications

• FDA 510(k)
• CE (MDD) Class I
• ISO 13485
• IEC 62304
• IEC 60601-1
• IEC 62366-1
• ISO 27001
• SOC 2
• HIPAA
• GDPR

Company Founding

2017

Company Offices

• South Korea
• United States
• Japan
• China
• Germany
• France
• United Kingdom
• India
• Brazil
• Australia

Compliance

• HIPAA
• GDPR
• ISO 27001
• SOC 2
• FDA 510(k)
• CE (MDD) Class I
• ISO 13485
• IEC 62304
• IEC 60601-1
• IEC 62366-1

Customers

Data Residency

US/EU regions

Data Standards

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

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Prostate cancer detection
• Medical image analysis
• Segmentation and measurement
• DICOM compatibility
• Cloud, hybrid, and on-premises deployment options
• Integration with PACS
• AI-powered diagnostics
• Regulatory compliance (CE Class I)

Id

SW0204

Integration Partners

Integrations

• PACS
• AI marketplaces
• Web-based standalone applications

Languages Supported

• English
• Korean

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Advanced analytics
• Reporting tools
• Patient management
• Clinical decision support
• Telemedicine integration
• Data visualization
• Workflow optimization
• Mobile access
• Cloud storage
• Data backup solutions

Os Platforms

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

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• Data residency controls
• Access controls
• Data retention policies
• User authentication
• Data integrity checks
• Regular security audits

Product Code

SW0204

Product Name

Medihub Prostate

Ratings

Regions Available

• United States
• South Korea
• global

Related Urls

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

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP
• Firewall
• Intrusion detection system
• Data masking
• Secure coding practices

Specialties

• Radiology
• Urology
• Oncology

Support Channels

System Requirements

• Windows Server 2016 or later
• Linux (Ubuntu 18.04 or later)
• macOS Mojave or later
• iOS 12 or later
• Android 9 or later
• 2 GB RAM minimum
• 500 MB free disk space
• Internet connection for cloud features

Target Users

• radiologists
• urologists
• clinicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Medihub Prostate",
  "company_name": "JLK",
  "product_url": "https://www.jlkinc.com/medihub-prostate",
  "company_url": "https://www.jlkinc.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0204",
  "summary": "Medihub Prostate is an AI-driven software developed by JLK Inc. to assist in diagnosing prostate cancer by analyzing MRI images and PSA levels.",
  "description": "Medihub Prostate is an AI-based diagnostic solution that analyzes prostate MRI images and assesses prostate-specific antigen (PSA) levels to aid in the detection of prostate cancer. Developed by JLK Inc. in collaboration with Seoul Asan Medical Center and the University of Missouri, it received FDA 510(k) clearance on June 21, 2024. The software semi-automatically outlines the prostate region in MRI images, requiring user editing and confirmation, and provides multiparametric MRI viewing and combined image visualization. It is intended for use by trained radiologists and urologists to support clinical decision-making without replacing expert judgment. The device has been validated for use with Siemens 3T Vida and Skyra MRI machines and is designed for patients aged 55 years and above. The software is accessible via a web browser and integrates multiple MRI sequences into single images, outputting structured reports including PI-RADS scores. Medihub Prostate has also secured a domestic technology patent in South Korea, further validating its technological excellence.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "radiology",
    "oncology Care",
    "imaging Software",
    "clinical Decision Support",
    "Diagnostic",
    "Clinical",
    "Radiology",
    "Oncology",
    "Ai-based Imaging Analysis"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "radiologists",
    "urologists",
    "clinicians"
  ],
  "specialties": [
    "Radiology",
    "Urology",
    "Oncology"
  ],
  "regions_available": [
    "United States",
    "South Korea",
    "global"
  ],
  "languages_supported": [
    "English",
    "Korean"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "South Korea",
    "United States",
    "Japan",
    "China",
    "Germany",
    "France",
    "United Kingdom",
    "India",
    "Brazil",
    "Australia"
  ],
  "company_founding": "2017",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Prostate cancer detection",
    "Medical image analysis",
    "Segmentation and measurement",
    "DICOM compatibility",
    "Cloud, hybrid, and on-premises deployment options",
    "Integration with PACS",
    "AI-powered diagnostics",
    "Regulatory compliance (CE Class I)"
  ],
  "optional_modules": [
    "Advanced analytics",
    "Reporting tools",
    "Patient management",
    "Clinical decision support",
    "Telemedicine integration",
    "Data visualization",
    "Workflow optimization",
    "Mobile access",
    "Cloud storage",
    "Data backup solutions"
  ],
  "integrations": [
    "PACS",
    "AI marketplaces",
    "Web-based standalone applications"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "unknown",
  "system_requirements": [
    "Windows Server 2016 or later",
    "Linux (Ubuntu 18.04 or later)",
    "macOS Mojave or later",
    "iOS 12 or later",
    "Android 9 or later",
    "2 GB RAM minimum",
    "500 MB free disk space",
    "Internet connection for cloud features"
  ],
  "compliance": [
    "HIPAA",
    "GDPR",
    "ISO 27001",
    "SOC 2",
    "FDA 510(k)",
    "CE (MDD) Class I",
    "ISO 13485",
    "IEC 62304",
    "IEC 60601-1",
    "IEC 62366-1"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE (MDD) Class I",
    "ISO 13485",
    "IEC 62304",
    "IEC 60601-1",
    "IEC 62366-1",
    "ISO 27001",
    "SOC 2",
    "HIPAA",
    "GDPR"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP",
    "Firewall",
    "Intrusion detection system",
    "Data masking",
    "Secure coding practices"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization",
    "Data residency controls",
    "Access controls",
    "Data retention policies",
    "User authentication",
    "Data integrity checks",
    "Regular security audits"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0204",
  "slug": "medihub-prostate",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/medihub-prostate.json"
  }
}