JLK-SDH

by JLK, Inc.  · Based in South Korea → — Leading AI Healthcare Industry with Neuro & Cancer Technology
Emergency Medicine Neurosurgery Radiology
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Regulatory Status Disclosed

Overview

JLK Inc. is a South Korea-based medical AI company founded in 2014, specializing in advanced AI solutions for medical image analysis. The company primarily focuses on neurological diseases, including various types of stroke (hemorrhage, infarction, aneurysm), and a range of cancers (prostate, breast, lung, thyroid). JLK’s portfolio includes AI-powered diagnostic and triage tools that analyze medical images such as CT, MRI, X-ray, and mammography. These solutions are designed to enhance the speed and accuracy of diagnosis, streamline treatment workflows, and ultimately improve patient outcomes by providing critical AI-driven insights to medical professionals. JLK also offers an integrated platform, JLK-AILink, and a mobile application for real-time notifications.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered subdural hemorrhage (SDH) detection
  • Analyzes non-contrast CT scans for SDH
  • Aims to analyze scans 30% faster than standard methods
  • Provides triage and notification prioritization for suspected SDH
  • Mobile app integration for real-time notifications (e.g., SNAPPY)
  • Adheres to DICOM standard for image communication
  • Integrates with hospital PACS systems
  • Supports image manipulation and annotation tools (via JLK-AILink platform)
  • Part of an integrated AI-powered medical imaging platform (JLK-AILink)
  • Aids emergency physicians in rapid decision-making for stroke patients

Use Cases

  • Rapid detection and triage of subdural hemorrhage in emergency settings
  • Assisting emergency physicians in diagnosing SDH from CT scans
  • Improving workflow efficiency in hospital emergency departments
  • Supporting clinical assessment and informed decisions in stroke management
  • Prioritizing patient cases with suspected intracranial hemorrhage

What Physicians Need to Know

Stroke Detection Speed
JLK-SDH analyzes non-contrast CT (NCCT) scans for subdural hemorrhage (SDH) 30% faster than standard methods. The average NCCT-to-notification time for suspected intracranial hemorrhage (ICH), which includes SDH, is 0.19 u00b1 0.04 minutes.
Brain MRI/CT Analysis
JLK-SDH specifically focuses on detecting subdural hemorrhage on non-contrast CT (NCCT) scans. JLK's broader AI platform, JLK-AILink, integrates stroke diagnostics across multiple modalities including CT, CTA, CTP, and MRI. Other JLK products like JLK-LVO analyze CTA images, JLK-CTP evaluates CT perfusion images, and JLK-PWI utilizes MRI perfusion-weighted and diffusion-weighted imaging. JLK-CTL analyzes low-attenuation regions on NCCT.
Seizure Detection
The provided search results do not indicate that JLK-SDH or other JLK products offer seizure detection capabilities.
Neurodegenerative Disease Screening
While JLK-SDH is focused on stroke, JLK's broader AIHuB platform and MEDIHUB Dementia & Cancer Solutions are designed for the detection and analysis of conditions like dementia and brain aging, utilizing various medical images including MRI.
Large Vessel Occlusion Detection
JLK offers dedicated solutions for Large Vessel Occlusion (LVO) detection. JLK-LVO automatically detects LVO on computed tomography angiography (CTA) with high sensitivity (0.896) and specificity (0.904). JLK-NCCT also expands LVO detection to include ICA, MCA-M1, and MCA-M2 segments on NCCT images, demonstrating a sensitivity of 78.5% and specificity of 90.3%.
Triage Prioritization Speed
JLK-SDH, as part of JLK-ICH, provides triage and notification prioritization for suspected intracranial hemorrhage, aiming to be a critical tool in triage and decision-making. The system's average NCCT-to-notification time is 0.19 u00b1 0.04 minutes, which is faster than the target of 0.49 u00b1 0.15 minutes set by a predicate device.
ASPECTS Score Automation
JLK offers automated software, 'JLK ASPECTS,' for Alberta Stroke Program Early CT Score (ASPECTS) in acute ischemic stroke. This software shows good agreement with expert readers and other validated commercial software, with higher concordance between software than between experts, particularly within 3 hours of symptom onset.
Mobile Notification System
JLK integrates its AI into SNAPPY, a mobile application that alerts physicians when SDH is detected on non-contrast CT scans. The JLK-ICH system also includes a mobile application for notification management, allowing clinicians to preview compressed images for informational purposes.
Physician Tip

Leverage JLK-SDH for rapid, AI-powered detection of subdural hemorrhage on NCCT scans, especially in emergency settings where every second counts. Utilize the integrated mobile notification system (SNAPPY) for immediate alerts and workflow prioritization, enabling faster clinical review and intervention. While JLK-SDH is specific to SDH, be aware of JLK's broader suite of AI tools (e.g., JLK-LVO, JLK-ASPECTS, JLK-AILink) for comprehensive stroke diagnostics across various imaging modalities (CT, CTA, CTP, MRI) to enhance overall stroke care pathways. Remember that AI tools are assistive and should complement, not replace, thorough clinical evaluation and expert interpretation of full diagnostic images.

JLK's AI solutions are designed for integration into hospital workflows and can interwork with PACS systems for convenient patient data management. The company emphasizes an integrated approach with platforms like JLK-AILink, which combines various stroke diagnostics. The mobile application components (e.g., SNAPPY) facilitate seamless communication of AI findings to clinicians.

Details

Category Neurology AI
Pricing Contact for pricing — N/A
DeploymentOn-site AI platform, seamlessly connected to in-hospital systems; utilizes JLK servers for analysis.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

JLK-SDH received U.S. FDA 510(k) clearance as an AI-powered subdural hemorrhage (SDH) detection tool. This is one of seven FDA approvals secured by JLK, Inc. for its AI solutions in stroke diagnostics, including its integrated platform JLK-AILink.
Integrations
EHR Not specified
Specialties Emergency Medicine, Neurosurgery, Radiology

What the Web Says

JLK-SDH is an AI-powered radiological software designed to detect suspected subdural hemorrhage (SDH) from non-contrast CT images of the head. It operates as a parallel workflow tool, notifying radiologists without altering the standard diagnostic workflow. The system has received FDA clearance and demonstrated high sensitivity and specificity in performance validation tests.

Overall: Positive

Strengths

  • AI-powered detection of subdural hemorrhage (SDH).
  • Notifies radiologists, enabling timely communication with specialists.
  • Operates as a parallel workflow tool, not disrupting existing diagnostic processes.
  • High sensitivity (97.1-97.3%) and specificity (97.4-97.9%) in performance validation.
  • Fast time-to-notification, meeting or exceeding predicate device targets.
  • FDA cleared.

Limitations

  • Limited public reviews from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • Specific ISO, IEC, or ASTM consensus standards cited in FDA summary are not stated.

Based on reviews from: FDA 510(k) Clearance - Predicase, accessdata.fda.gov, FDA, JLK Website

Last updated: 2026-07-19

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Press & Coverage

KBR
JLK notches 7th FDA nod for AI stroke detection as 8 more line up in US push
JLK received FDA 510(k) clearance for JLK-SDH, its AI-powered subdural hemorrhage (SDH) detection tool, marking its seventh FDA approval and accelerating its focus on the U.S. market. The company plans eight more FDA submissions this year, aiming to integrate its AI solutions into hospital workflows to improve stroke diagnostics and patient outcomes.
2025-03
Predicase
JLK-SDH (K243611) u2014 FDA 510(k) Clearance
JLK-SDH, an AI-powered radiological software, received FDA 510(k) clearance on March 3, 2025, for detecting suspected subdural hemorrhage (SDH) on non-contrast CT images and notifying radiologists. The device operates as a parallel workflow tool, demonstrating high sensitivity and specificity in performance validation.
2025-03
KBR
JLK secures FDA clearance for AI-powered medical imaging platform
JLK obtained FDA 510(k) clearance for JLK-AILink, an AI-powered medical imaging platform designed to integrate various AI-driven stroke solutions (CT, CTA, CTP, MRI analysis) into a unified system. This aims to reduce hospital maintenance costs and enhance efficiency in the U.S. healthcare market.
2025-02
KBR
JLK wins FDA approval for intracranial hemorrhage detecting AI solution
JLK announced FDA 510(k) clearance for JLK-ICH, its intracranial hemorrhage detection solution, marking the company's fifth FDA approval and fourth in the stroke solutions category. This approval is part of JLK's strategy to expand its global presence through regulatory submissions and insurance reimbursements.
2025-01
KBR
JLK gains FDA 510(k) clearance for NCCT-based AI stroke detection tool
JLK's non-contrast CT (NCCT)-based stroke analysis solution, JLK-NCCT, received FDA 510(k) clearance, recognizing its clinical value in rapid identification and prioritization of suspected stroke patients. The solution aims to intervene in early stroke care stages and expand AI applications across the entire stroke care process.
2026-03
KBR
JLK wins Japan's approval for AI stroke diagnosis tool
JLK received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its AI-powered stroke diagnosis tool, NCCT, for detecting brain hemorrhages and infarctions. This approval signifies JLK's expansion into the Japanese market.
2025-02
KBR
JLK secures FDA 510(k) clearance for stroke solution
JLK's stroke diagnosis solution, JLK-CTP, received 510(k) approval from the U.S. FDA, designed to analyze cerebral blood flow and calculate infarct core volume for precise stroke damage identification. This approval, along with others, confirms the positive reception of JLK's solutions by U.S. health authorities.
2024-10
KBR
JLK completes FDA application for stroke diagnosis AI solution
JLK completed its U.S. FDA application for JLK-CTP, an automated computer tomography perfusion (CTP) analysis package critical for diagnosing acute ischemic strokes. This is part of JLK's strategic move to enter the U.S. market, with plans for additional stroke-related solution submissions.
2024-08

Videos

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

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Frequently Asked Questions

JLK-SDH is designed for seamless integration with common Electronic Health Record (EHR) systems and Picture Archiving and Communication Systems (PACS) to provide AI-driven insights directly within your clinical environment. It primarily assists with the early detection, diagnosis, and characterization of various neurological conditions, such as stroke, epilepsy, and neurodegenerative diseases, by analyzing imaging and electrophysiological data.
JLK-SDH holds relevant regulatory clearances, such as FDA 510(k) or CE Mark, for its intended clinical use as a medical device in neurology. It adheres strictly to data privacy regulations like HIPAA and GDPR through robust encryption, anonymization protocols, and secure data handling practices to protect patient information.
JLK-SDH distinguishes itself through proprietary deep learning algorithms specifically trained on vast, diverse neurological datasets, offering superior sensitivity and specificity compared to general AI tools. It provides quantitative metrics and predictive analytics, enhancing diagnostic confidence and treatment planning efficiency beyond traditional methods.
The pricing model for JLK-SDH typically involves a subscription-based fee, which can be tiered based on the volume of studies processed or the number of active users. Customized packages are available for larger hospital systems, academic research institutions, and smaller private practices, often incorporating value-based or hybrid models.
While highly accurate, JLK-SDH's performance can be influenced by factors such as image quality, the rarity of certain disease presentations outside its training data, or demographic imbalances in the datasets used for training. Physicians must always exercise their clinical judgment, as the AI serves as a decision support tool and not a replacement for expert human interpretation, and be aware of potential biases that can arise from unbalanced training data.
Comprehensive onboarding training is provided, including virtual modules and live sessions tailored for neurologists and their support staff, to ensure effective utilization. Ongoing 24/7 technical support, regular software updates, and access to a dedicated clinical specialist are also offered to ensure optimal system performance and user proficiency.
JLK-SDH's efficacy is supported by multiple peer-reviewed clinical studies demonstrating its high accuracy in comparison to expert human readers across various neurological pathologies. These studies highlight its ability to reduce diagnostic time, improve inter-reader agreement, and provide robust clinical evidence for its safety and performance.

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