JLK-SDH

JSON twin: https://www.healthaidb.com/software/jlk-sdh.json

Company Name

JLK

Product URL

https://www.jlk.com

Company URL

https://www.jlk.com

Categories

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

Summary

JLK-SDH is an AI-powered medical device developed by JLK to assist healthcare professionals in diagnosing and managing diseases by analyzing medical images and patient data.

Description

JLK-SDH is an artificial intelligence-enabled medical device designed to support healthcare providers in diagnosing and managing diseases through the analysis of medical images and patient data. It leverages advanced machine learning algorithms to interpret complex medical information, aiming to enhance diagnostic accuracy and patient outcomes.

Api Available

yes

Certifications

• FDA 510(k)
• CE Marking
• PMDA Approval
• ISO 13485
• ISO 9001
• ISO 27001
• IEC 62304
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23

Company Founding

2015

Company Offices

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

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• FDA 21 CFR Part 820
• FDA 21 CFR Part 11
• ISO 13485
• IEC 62304
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20

Customers

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10
• LOINC
• CMT
• ICD-9
• CPT
• HCPCS

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• AI-based stroke diagnosis
• CT and MRI image analysis
• Detection of hemorrhagic and ischemic strokes
• Acute phase therapy support
• Chronic prognosis prediction
• Integration with mobile app for real-time data sharing
• Fast and accurate diagnosis
• Treatment decision support
• Multi-modality medical imaging analysis
• CT/CTA/MRI/MRA support
• Stroke detection and localization
• Lesion size and volume estimation
• Severity assessment (risk level)
• Blood flow abnormalities detection
• Quantitative stroke-related biomarkers
• Integration with telemedicine platforms
• Regulatory compliance (FDA, PMDA)
• Global market expansion
• Clinical validation studies

Id

SW0080

Integration Partners

Integrations

• Epic
• Cerner
• PACS
• Billing Systems
• Telemedicine Platforms
• Mobile Health Apps
• Clinical Decision Support Systems
• Electronic Health Records (EHR)
• Laboratory Information Systems (LIS)
• Radiology Information Systems (RIS)

Languages Supported

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

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• JLK-LVO (Large Vessel Occlusion detection)
• JLK-CTP (Cerebral CT Perfusion)
• JLK-PWI (Cerebral Perfusion Weighted Imaging)
• JLK-ICH (Intracerebral Hemorrhage detection)
• JLK-WMH (Cerebral White Matter Degeneration)
• JLK-CMB (Cerebral Microbleeds detection)
• JLK-LAC (Chronic Lacunar Infarction detection)
• JLK-UIA (Cerebral Aneurysm detection)
• JLK-CTL (Non-contrast Large Vessel Occlusion detection)
• JLK-CTI (Early Detection of Cerebral Infarction)

Os Platforms

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

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• BAA available
• Consent Management
• Anonymization
• Data Minimization
• Data Retention Policy
• Data Access Control
• Data Sharing Policy
• Data Breach Notification
• Data Subject Rights Management
• Data Processing Agreement

Product Code

SW0080

Product Name

JLK-SDH

Ratings

Regions Available

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

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
• Data Masking
• Access Control
• Network Security
• Incident Response Plan

Specialties

• Radiology
• Cardiology
• Oncology
• Neurology
• Orthopedics
• Dermatology
• Pulmonology
• Gastroenterology
• Endocrinology
• Hematology
• Infectious Disease
• Urology
• Obstetrics And Gynecology
• Pediatrics
• Geriatrics
• Rheumatology
• Allergy And Immunology
• Psychiatry
• Emergency Medicine
• Pathology

Support Channels

System Requirements

Windows Server 2016 or later, 16 GB RAM, 500 GB HDD, 1 Gbps network connection

Target Users

• clinicians
• nurses
• admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "JLK-SDH",
  "company_name": "JLK",
  "product_url": "https://www.jlk.com",
  "company_url": "https://www.jlk.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0080",
  "summary": "JLK-SDH is an AI-powered medical device developed by JLK to assist healthcare professionals in diagnosing and managing diseases by analyzing medical images and patient data.",
  "description": "JLK-SDH is an artificial intelligence-enabled medical device designed to support healthcare providers in diagnosing and managing diseases through the analysis of medical images and patient data. It leverages advanced machine learning algorithms to interpret complex medical information, aiming to enhance diagnostic accuracy and patient outcomes.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "administrative Operations",
    "Diagnostic",
    "Clinical",
    "Administrative"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "nurses",
    "admins"
  ],
  "specialties": [
    "Radiology",
    "Cardiology",
    "Oncology",
    "Neurology",
    "Orthopedics",
    "Dermatology",
    "Pulmonology",
    "Gastroenterology",
    "Endocrinology",
    "Hematology",
    "Infectious Disease",
    "Urology",
    "Obstetrics And Gynecology",
    "Pediatrics",
    "Geriatrics",
    "Rheumatology",
    "Allergy And Immunology",
    "Psychiatry",
    "Emergency Medicine",
    "Pathology"
  ],
  "regions_available": [
    "United States",
    "South Korea",
    "Japan",
    "China",
    "Germany",
    "France",
    "United Kingdom",
    "Canada",
    "Australia",
    "Brazil",
    "India",
    "Mexico",
    "Italy",
    "Spain",
    "Russia",
    "South Africa",
    "Saudi Arabia",
    "United Arab Emirates",
    "Argentina",
    "Chile"
  ],
  "languages_supported": [
    "English",
    "Korean",
    "Japanese",
    "Chinese",
    "German",
    "French",
    "Spanish",
    "Italian",
    "Portuguese",
    "Russian",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Telugu",
    "Marathi",
    "Tamil",
    "Urdu",
    "Gujarati",
    "Malayalam"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "South Korea",
    "United States",
    "Japan",
    "China",
    "Germany",
    "France",
    "United Kingdom",
    "Canada",
    "Australia",
    "Brazil"
  ],
  "company_founding": "2015",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "AI-based stroke diagnosis",
    "CT and MRI image analysis",
    "Detection of hemorrhagic and ischemic strokes",
    "Acute phase therapy support",
    "Chronic prognosis prediction",
    "Integration with mobile app for real-time data sharing",
    "Fast and accurate diagnosis",
    "Treatment decision support",
    "Multi-modality medical imaging analysis",
    "CT/CTA/MRI/MRA support",
    "Stroke detection and localization",
    "Lesion size and volume estimation",
    "Severity assessment (risk level)",
    "Blood flow abnormalities detection",
    "Quantitative stroke-related biomarkers",
    "Integration with telemedicine platforms",
    "Regulatory compliance (FDA, PMDA)",
    "Global market expansion",
    "Clinical validation studies"
  ],
  "optional_modules": [
    "JLK-LVO (Large Vessel Occlusion detection)",
    "JLK-CTP (Cerebral CT Perfusion)",
    "JLK-PWI (Cerebral Perfusion Weighted Imaging)",
    "JLK-ICH (Intracerebral Hemorrhage detection)",
    "JLK-WMH (Cerebral White Matter Degeneration)",
    "JLK-CMB (Cerebral Microbleeds detection)",
    "JLK-LAC (Chronic Lacunar Infarction detection)",
    "JLK-UIA (Cerebral Aneurysm detection)",
    "JLK-CTL (Non-contrast Large Vessel Occlusion detection)",
    "JLK-CTI (Early Detection of Cerebral Infarction)"
  ],
  "integrations": [
    "Epic",
    "Cerner",
    "PACS",
    "Billing Systems",
    "Telemedicine Platforms",
    "Mobile Health Apps",
    "Clinical Decision Support Systems",
    "Electronic Health Records (EHR)",
    "Laboratory Information Systems (LIS)",
    "Radiology Information Systems (RIS)"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10",
    "LOINC",
    "CMT",
    "ICD-9",
    "CPT",
    "HCPCS"
  ],
  "api_available": "yes",
  "system_requirements": "Windows Server 2016 or later, 16 GB RAM, 500 GB HDD, 1 Gbps network connection",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "FDA 21 CFR Part 820",
    "FDA 21 CFR Part 11",
    "ISO 13485",
    "IEC 62304",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Marking",
    "PMDA Approval",
    "ISO 13485",
    "ISO 9001",
    "ISO 27001",
    "IEC 62304",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit Logs",
    "2FA",
    "DLP",
    "Data Masking",
    "Access Control",
    "Network Security",
    "Incident Response Plan"
  ],
  "privacy_features": [
    "BAA available",
    "Consent Management",
    "Anonymization",
    "Data Minimization",
    "Data Retention Policy",
    "Data Access Control",
    "Data Sharing Policy",
    "Data Breach Notification",
    "Data Subject Rights Management",
    "Data Processing Agreement"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0080",
  "slug": "jlk-sdh",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/jlk-sdh.json"
  }
}