JLK-NCCT
Regulatory Status Disclosed
Overview
JLK-NCCT is an AI-powered medical device designed to assist healthcare professionals in the analysis of non-contrast computed tomography (NCCT) brain scans. This software aims to enhance the efficiency and accuracy of identifying critical findings, particularly those associated with acute ischemic stroke.
The tool processes NCCT images to highlight areas of interest, providing quantitative and qualitative data that can aid physicians in making timely diagnostic and treatment decisions. By automating parts of the image analysis workflow, JLK-NCCT seeks to reduce the time to diagnosis, which is crucial in time-sensitive conditions like stroke where early intervention significantly impacts patient outcomes.
JLK-NCCT is intended to be used as an adjunct to, and not a replacement for, the physician’s expert judgment. It provides a layer of computational analysis to support radiologists and neurologists in their interpretation of complex imaging data, potentially leading to improved patient care pathways and resource allocation within emergency and stroke units.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered non-contrast CT brain scan analysis
- Assists in acute ischemic stroke detection
- Highlights areas of interest on NCCT images
- Provides quantitative and qualitative data
- Aids in timely diagnostic decisions
- Designed to improve workflow efficiency
Use Cases
- Assisting radiologists in NCCT brain scan interpretation
- Supporting neurologists in stroke diagnosis
- Expediting critical findings in emergency settings
- Enhancing diagnostic accuracy for acute ischemic stroke
- Improving patient outcomes through faster intervention
What Physicians Need to Know
Evidence Base
JLK-NCCT is an AI-powered solution for stroke analysis based on non-contrast CT (NCCT) images. It is designed to screen for patients suspected of intracerebral hemorrhage and identify those with suspected large-vessel occlusion (LVO) among patients with cerebral infarction. The tool's development involved analyzing hemispheric differences in Hounsfield units, regional brain volume, and the presence of a clot sign in the middle cerebral artery (MCA). It expands the analysis scope beyond the internal carotid artery (ICA) and M1 segment of the MCA to include the peripheral M2 region, increasing the likelihood of detecting peripheral vascular occlusions.
Clinical Validation Studies
JLK-NCCT has received FDA 510(k) clearance. A multicenter study validated JLK-CTL (a component or earlier version of JLK-NCCT) in patients who visited hospitals within 24 hours of their last known well. This study, involving 6 comprehensive stroke centers, demonstrated robust diagnostic accuracy with an area under the receiver operating characteristic curve (AUC-ROC) of 0.859 (95% CI, 0.827u20130.887) for predicting LVO using only NCCT. In a real-world reader study, JLK-NCCT showed a sensitivity of 78.5% and a specificity of 90.3% in detecting suspected LVO on NCCT, compared to radiologists' average sensitivity of 56.8% and specificity of 84.0% without AI assistance. Another multinational validation study across Korean and US cohorts showed standalone AI AUC values of 0.963 (95% CI 0.946 to 0.975) and 0.899 (95% CI 0.858 to 0.939) respectively. AI assistance significantly increased pooled AUC values from 0.718 to 0.852, sensitivity from 46.6% to 63.7%, and specificity from 91.9% to 94.9% (all P<0.001) for clinicians. The JLK CTL LVO score also showed a strong correlation with infarct volume and independently predicted poor 3-month functional outcomes.
Differential Diagnosis Support
JLK-NCCT is designed to screen for patients suspected of intracerebral hemorrhage while simultaneously identifying those with suspected large-vessel occlusion (LVO) among patients with cerebral infarction. This capability aids in the early identification of LVO, which is typically assessed via CT angiography (CTA), even at the NCCT stage. This supports rapid patient triage and response in the emergency room, prioritizing patients needing urgent procedures like thrombectomy.
Clinical Workflow Integration
JLK-NCCT is positioned as a core platform supporting JLK's broader stroke AI solutions across the clinical workflow. By applying an AI solution at the non-contrast CT stage, which is the primary test for most stroke patients, it can create a seamless pathway to subsequent tests such as CTA, CT perfusion, and MRI, as well as to treatment. The system provides automated notifications to clinicians to prioritize review, allowing faster communication and potentially improving patient outcomes. The technology utilizes an AI/ML algorithm hosted on servers to analyze NCCT scans, compatible with DICOM standards, with results sent through a mobile application for notification. The mean notification time averages 0.19 minutes.
Physician Tip
Leverage JLK-NCCT for rapid screening of suspected stroke patients, particularly for early identification of large-vessel occlusion (LVO) directly from non-contrast CT scans, which can significantly reduce time to treatment in the critical 'golden hour'. Integrate the automated notifications into your workflow to prioritize cases requiring urgent attention. While the AI significantly improves diagnostic accuracy, always use it as a supportive tool in conjunction with your clinical expertise and consider subsequent imaging for definitive diagnosis and treatment planning. The tool's ability to detect peripheral vascular occlusions, often overlooked, can be particularly valuable.
JLK-NCCT is designed to integrate seamlessly into existing clinical workflows by analyzing DICOM-compliant NCCT images and delivering results via mobile application for rapid clinician notification. It serves as a foundational component for JLK's comprehensive stroke AI portfolio, facilitating a streamlined pathway from initial NCCT to advanced imaging (CTA, CTP, MRI) and subsequent treatment decisions.
Details
| Category | Clinical Decision Support & Reference, Neurology AI, Radiology & Imaging AI |
| Pricing | Unknown — unknown |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status | Cleared AI-estimated — unknown |
| Integrations | |
| EHR | Not specified |
| Specialties | Emergency Medicine, Neurology, Radiology |
Social Proof
| Customers | unknown |
Ratings & Reviews
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Press & Coverage
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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 can screen for intracerebral hemorrhage and identify suspected large-vessel occlusion (LVO) in cerebral infarction patients, even at the NCCT stage.
2026-03
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uc81cuc774uc5d8ucf00uc774, ube44uc870uc601 CT uae30ubc18 ub1ccuc878uc911 ubd84uc11d uc194ub8e8uc158 u7f8e FDA ud5c8uac00 ud68dub4dd - ubc14uc774uc624ud0c0uc784uc988
JLK announced that its non-contrast CT (NCCT)-based stroke analysis solution, 'JLK-NCCT,' has received 510(k) Clearance from the U.S. FDA, marking a significant step for its entry into the American market. This approval acknowledges the AI technology's clinical value in supporting the rapid screening and prioritization of suspected stroke patients during the initial NCCT stage of stroke care.
2026-03
Innolitics
JLK-NCCT (K252421) u2014 FDA 510(k) | Innolitics
JLK-NCCT, a radiological computer-aided triage software, received FDA 510(k) clearance on March 24, 2026, under regulatory classification QAS. This regulatory announcement confirms the device's approval for market use.
2026-03
FDA
Artificial Intelligence-Enabled Medical Devices - FDA
The FDA lists JLK-NCCT by JLK, Inc. as an AI-enabled medical device in Radiology, with a 510(k) clearance date of March 24, 2026. This indicates its compliance with FDA premarket requirements for safety and effectiveness.
2026-03
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uc81cuc774uc5d8ucf00uc774, ub1ccuc878uc911 ubd84uc11d uc194ub8e8uc158 u7f8e FDA 510k ud68dub4dd - ud31cuc774ub370uc77cub9ac
JLK announced on March 26 that its non-contrast CT (NCCT)-based stroke analysis solution, 'JLK-NCCT,' received FDA 510(k) Clearance. This clearance is significant as it recognizes the clinical value of AI technology in supporting rapid identification and prioritization of suspected stroke patients during the initial NCCT stage.
2026-03
KBR
JLK snags 4th Japan nod for stroke AI, targets underserved hospitals - KBR
JLK secured its fourth regulatory approval in Japan for its MRI-based stroke diagnosis solution, JLK-FLAIR, building on its existing stroke-focused AI suite which includes JLK-NCCT. The company aims to address specialist shortages in Japan's aging healthcare system with its expanding portfolio of imaging modalities.
2025-03
KORIT
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JLK has obtained various AI product approvals in the US and Japan, including JLK-NCCT, and is now focusing on commercialization by supplying products to hospitals and securing insurance coverage. The company aims to accelerate its global market strategy through partnerships and expanding its product lineup.
2025-04
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JLK has secured an official distribution channel in Japan through a strategic agreement with Clairvo Technologies, a healthcare subsidiary of Marubeni, to supply AI-based CT analysis solutions like JLK-CTP and JLK-NCCT. This move is expected to accelerate JLK's entry into the Japanese market and contribute to significant sales growth.
2025-07
Frequently Asked Questions
JLK-NCCT is a medical AI solution designed to assist in the analysis of NCCT scans, particularly for stroke detection. It integrates into your workflow by providing automated analysis and reports that can be viewed alongside the original imaging, aiming to offer rapid insights for clinical decision-making.
JLK-NCCT adheres to relevant medical device regulations and maintains strict protocols for patient data privacy. It is designed to be compliant with standards like HIPAA and GDPR, ensuring secure handling and processing of sensitive patient information.
Alternatives to JLK-NCCT include other AI-powered diagnostic tools and traditional radiologist interpretation. JLK-NCCT differentiates itself through its reported speed and accuracy in detecting specific pathologies on NCCT scans, potentially reducing diagnostic times and improving patient outcomes.
The pricing model for JLK-NCCT typically involves subscription-based options, with different tiers available to accommodate the needs of various clinical settings, from individual practices to large hospital networks. Specific pricing details are usually provided upon direct inquiry to account for customized integration and usage.
While highly effective, JLK-NCCT has limitations, particularly in cases of subtle or atypical presentations where human expert interpretation remains crucial. It should be used as a decision support tool, not a replacement for comprehensive clinical judgment, especially in complex or ambiguous cases.
JLK-NCCT is designed to minimize false positives and negatives through advanced AI algorithms, with reported high accuracy rates in real-world clinical settings. However, like all diagnostic tools, it is not infallible, and any discrepancies should prompt further clinical review.
Comprehensive training and ongoing technical support are provided with JLK-NCCT to ensure seamless integration and optimal usage by medical staff. This includes initial onboarding, user manuals, and access to support specialists for any technical or operational queries.
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| Last Verified: 2026-08-19 | First Added: 2026-08-19