JLK-ICH

by JLK, Inc.  · Based in South Korea → — AI-powered Rapid Detection for Intracranial Hemorrhage
Emergency Medicine Neurology Radiology
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Regulatory Status Disclosed

Overview

JLK-ICH is a radiological computer-assisted triage and notification (CADt) software developed by JLK, Inc. It is designed to analyze non-contrast Computed Tomography (NCCT) images of the head to detect suspected hemispheric intracranial hemorrhage (ICH) and provide prioritized triage and notification. This AI/ML-based algorithm functions as a notification-only, parallel workflow tool, assisting hospital networks and trained clinicians in identifying and communicating suspected patient images to relevant specialists, independent of the standard care workflow. The system aims to improve stroke prognosis by shortening the diagnosis and treatment workflow. It comprises an image analysis algorithm hosted on JLK servers and includes a mobile application for notification management. JLK-ICH has demonstrated high accuracy in detecting all ICH subtypes and has been shown to improve diagnostic accuracy for non-expert readers with deep learning assistance.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based analysis of non-contrast CT (NCCT) images of the head
  • Detection of suspected hemispheric intracranial hemorrhage (ICH)
  • Computer-assisted triage and notification (CADt)
  • Notification-only, parallel workflow tool
  • Mobile application for notification management and non-diagnostic image viewing
  • Adherence to DICOM standard
  • Integration with existing stroke solutions (e.g., JLK-LVO, JLK-CTP, JLK-PWI) for enhanced diagnostic accuracy
  • High accuracy in detecting all ICH subtypes
  • Improved diagnostic accuracy for non-expert readers with AI assistance

Use Cases

  • Rapid detection and notification of suspected intracranial hemorrhage in emergency settings
  • Assisting hospital networks and clinicians in prioritizing patient images for specialist review
  • Shortening the workflow of stroke diagnosis and treatment
  • Enhancing diagnostic accuracy across the stroke care continuum

What Physicians Need to Know

Stroke Detection Speed
JLK-ICH is designed for rapid diagnosis and intervention of intracranial hemorrhages on brain CT images, crucial for improving patient outcomes. The overall JLK stroke platform aims to shorten the workflow from diagnosis to treatment. JLK-LVO is a real-time software tool for large vessel occlusion detection, built for emergency use.
Brain MRI/CT Analysis
JLK-ICH analyzes brain CT images to detect and classify intracranial hemorrhages (ICH, IVH, SAH, SDH, EDH) with high accuracy across all subtypes. The comprehensive 'MEDIHUB STROKE' solution offers multi-modality analysis including CT, CTA, MRI, and MRA for all stroke types. Specific modules include JLK-LVO for large vessel occlusion on CTA, JLK-CTP for brain perfusion analysis on CT, JLK-DWI for cerebral infarction detection and subtype classification on DWI MR images, and JBA-01K (JLK-UIA) for cerebral aneurysm detection on MRA.
Neurodegenerative Disease Screening
JLK offers JAD-02K, an AI system that classifies gray matter, calculates cortical thickness using MRI, and estimates brain aging status. JLK's AI medical solutions also address dementia.
Large Vessel Occlusion Detection
JLK-LVO is a real-time AI software for detecting large vessel occlusion (LVO) on CT angiography (CTA). It has demonstrated high detection rates, with an AUROC of 0.944 (sensitivity 0.896, specificity 0.904) in one multicenter study and a sensitivity of 0.858 and specificity of 0.969 in another. JLK-LVO also showed higher specificity (0.96 vs. 0.89) compared to RAPID CTA at a matched sensitivity of 83%.
Triage Prioritization Speed
JLK-ICH is designed to be utilized in the initial diagnostic process for stroke patients in emergency rooms, enabling rapid diagnosis. JLK-LVO is built for emergency use to quickly identify suspected blockages. The integrated JLK-AILink platform is optimized for high-volume patient management in hospitals, with a mobile version enhancing usability in emergency situations.
ASPECTS Score Automation
JLK ASPECTS is an automated software for the Alberta Stroke Program Early CT Score (ASPECTS). It shows good agreement with expert readers and other commercial software, particularly within 3 hours of stroke onset. The automated ASPECTS scores correlated significantly with DWI infarct volume and effectively identified large infarcts.
Mobile Notification System
The JLK-AILink AI-powered medical imaging platform includes mobile notifications with real-time updates for critical findings. Additionally, JLK's MEDIHUB TELE platform allows users to check AI analysis results via mobile phone.
Physician Tip

Leverage JLK-ICH for rapid and accurate detection of intracranial hemorrhage on CT scans, especially in emergency settings, to facilitate timely intervention. Utilize the comprehensive stroke suite (JLK-LVO, JLK-CTP, JLK-PWI, JLK-DWI, JLK-ASPECTS) for a full spectrum of stroke diagnosis, from LVO detection and perfusion analysis to ischemic core quantification and stroke subtype classification. For non-expert readers, JLK-ICH and JLK-LVO can significantly improve diagnostic accuracy, acting as a valuable second opinion or primary screening tool. Integrate the mobile notification system for real-time alerts on critical findings, enabling faster response times and improved patient triage. Consider JLK's solutions for neurodegenerative disease screening (JAD-02K) to aid in early detection and monitoring of conditions like brain aging and dementia.

JLK's solutions, including JLK-ICH, are designed to integrate with existing stroke solutions (JLK-LVO, JLK-CTP, JLK-PWI) to enhance diagnostic accuracy and support treatment decisions across the entire stroke care continuum. The JLK-AILink platform provides a unified system for medical imaging management and data analysis, adhering to DICOM standards for high security and stability. This integrated approach consolidates AI-driven solutions for stroke workflow improvements, aiming to reduce maintenance costs and streamline hospital management.

Details

Category Neurology AI, Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Contact for pricing
DeploymentJLK servers (cloud-based, with mobile app integration)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

JLK-ICH received FDA 510(k) clearance as a radiological computer-assisted triage and notification (CADt) software for suspected hemispheric intracranial hemorrhage (ICH) from non-contrast CT images. It is a notification-only, parallel workflow tool.
Integrations
EHR Not specified
Specialties Emergency Medicine, Neurology, Radiology

What the Web Says

JLK-ICH is an AI-powered solution designed to detect intracranial hemorrhage (ICH) from non-contrast CT images of the brain, aiming to improve the speed and accuracy of diagnosis and notification for medical specialists. It has received FDA 510(k) clearance and is considered substantially equivalent to the Viz ICH system. The system is intended to be a notification-only, parallel workflow tool that assists clinicians in identifying and communicating suspected ICH cases, rather than for diagnostic use beyond notification.

Overall: Mixed

Strengths

  • Efficient triage with rapid notification times for suspected ICH cases.
  • High accuracy in detecting all ICH subtypes.
  • Significantly improves diagnostic accuracy for non-expert readers.
  • Maintains high accuracy across various ICH subtypes and performs well in 'difficult cases'.
  • Integrates with JLK's existing stroke solutions to enhance diagnostic accuracy and support treatment decisions across the stroke care continuum.
  • FDA 510(k) clearance without requiring additional revisions.

Limitations

  • Frequent false-positive alerts are a central driver of dissatisfaction among radiologists.
  • Time spent reviewing false-positive alerts can outweigh the tool's benefits.
  • Some radiologists perceive the AI as not correctly identifying most ICH cases.
  • Concerns about legal vulnerability if overriding an AI recommendation.
  • The device does not mark, highlight, or direct users' attention to a specific location in the original image.
  • Identification of suspected findings is not for diagnostic use beyond notification.

Based on reviews from: accessdata.fda.gov, KBR, PubMed, KED Global, PMC, Health AI Register, JLK Group, JMIR Human Factors

Last updated: 2026-07-18

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Press & Coverage

KBR
JLK wins FDA approval for intracranial hemorrhage detecting AI solution
JLK's intracranial hemorrhage detection solution, JLK-ICH, received FDA 510(k) clearance, marking the company's fifth FDA approval and fourth in stroke solutions. The AI solution analyzes brain CT images to detect intracranial hemorrhage, aiming to enhance diagnostic accuracy and support treatment decisions.
2025-01
accessdata.fda.gov
JLK-ICH (K243363) u2014 FDA 510(k)
JLK-ICH is a radiological computer-assisted triage and notification software that analyzes non-contrast CT images to detect suspected intracranial hemorrhage and provides notification to clinicians. The device was found substantially equivalent to the predicate device Viz ICH (K193658) in terms of safety and effectiveness.
2025-01
KED Global
JLK gets OK from FDA for ICH diagnosis solution
South Korea's JLK Inc. received FDA 510(k) approval for its AI-based intracerebral hemorrhage (ICH) diagnosis solution, JLK-ICH. This solution analyzes CT images to detect brain hemorrhage and will integrate with JLK's other stroke solutions for comprehensive stroke care.
2025-01
PMC (PubMed Central)
Deep learning-assisted detection of intracranial hemorrhage: validation and impact on reader performance
This clinical trial validated the JLK-ICH deep learning algorithm for ICH detection, demonstrating high accuracy (98.7% sensitivity, 88.5% specificity) and significant improvement in diagnostic accuracy for non-expert readers with AI assistance. The study evaluated 1,370 CT scans and found improved performance, especially in low-confidence cases.
2025-03
KBR
JLK to supply healthcare AI solutions to Indonesia's largest hospital
JLK signed an agreement to supply medical AI solutions, including JLK-ICH for brain hemorrhage detection, to Siloam Hospitals, Indonesia's largest hospital chain. This partnership aims to create a digital healthcare ecosystem in Indonesia and expand JLK's global presence.
2024-04
Wiltse Memorial Hospital
Wiltse Memorial Hospital Introduces Advanced AI Solution for Stroke Diagnosis
Wiltse Memorial Hospital adopted JLK's AI solution for stroke diagnosis, including JLK-ICH for brain hemorrhage detection. This solution analyzes CT and MRI images in real-time to reduce diagnosis time and increase accuracy for stroke patients.
2024-07
MK
JLK announced on the 9th that the Artificial Intelligence (AI) voucher support project, which is und..
JLK and Keimyung University Dongsan Hospital are collaborating on a government-supported AI voucher project to improve emergency room care processes and expand medical field applications using JLK's four AI-based stroke diagnosis solutions, including JLK-ICH. The project aims to verify clinical performance with patient data and publish findings.
2025-07
ResearchGate
Systematic review of commercial artificial intelligence tools for the detection and volume quantification in intracerebral hemorrhage
A systematic review identified JLK-ICH as one of 19 commercial AI tools for intracerebral hemorrhage detection and quantification, noting its FDA 510(k) Class II certification. The review highlights the need for standardized validation and greater transparency in studies of these tools.
2025-07

Videos

Product demos, reviews, and walkthroughs for JLK-ICH.

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Frequently Asked Questions

JLK-ICH is designed for seamless integration with major Electronic Health Record (EHR) systems through secure APIs, allowing physicians to access AI-driven insights directly within their patient charts. It aims to augment clinical decision-making by providing real-time data analysis and predictive analytics without disrupting established protocols.
Yes, JLK-ICH is built with robust security measures and adheres strictly to HIPAA, GDPR, and other pertinent healthcare data privacy regulations. All patient data processed by JLK-ICH is de-identified and encrypted to ensure maximum confidentiality and compliance.
JLK-ICH distinguishes itself through its specialized focus on personalized treatment recommendations for chronic diseases and its proprietary explainable AI (XAI) framework, which provides transparent reasoning for its recommendations. This allows physicians to better understand and trust the AI's insights, unlike many black-box models.
JLK-ICH offers flexible subscription tiers, including per-user licenses and volume-based pricing, with special considerations for academic research and smaller independent practices. Detailed pricing information and potential pilot programs can be discussed with our sales team to find a suitable solution for your specific needs.
While highly accurate, JLK-ICH's performance is optimized for specific data types and may have limitations with rare diseases or highly atypical patient presentations not well-represented in its training data. We continuously monitor for algorithmic bias and provide clear guidelines on its appropriate use to ensure physicians understand its scope and limitations.
JLK-ICH employs a rigorous validation process, including extensive testing against real-world clinical data and continuous monitoring by a team of medical experts and data scientists. Its algorithms are regularly updated and retrained to maintain high levels of accuracy and adapt to evolving medical knowledge.
We offer comprehensive onboarding, training modules, and ongoing technical support to ensure physicians can effectively utilize JLK-ICH within their practice. Our support team is available to assist with integration, troubleshooting, and optimizing the AI's performance for individual clinical needs.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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