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Medical AIKOSDAQ 322510MAA MemberInnovative Medical Device75 approvals

JLK, Inc.

Official website

JLK offers the stroke AI solution MEDIHUB STROKE and holds 78 global regulatory approvals, including US FDA and Japan PMDA clearances.

As of 2026-10-09, JLK, Inc. has 3 MFDS Innovative Medical Device designations, 64 Korean MFDS device approvals, 8 US FDA clearances/approvals, 73 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2014 and listed on KOSDAQ in 2019, JLK is a medical AI solution company specializing in image and clinical data analysis for disease diagnosis. It provides MEDIHUB STROKE, a suite of 12 stroke-analysis solutions based on CT, CTP, CTA, and MRI imaging; JLK-LVO, JLK-CTP, JLK-PWI, JLK-ICH, and JLK-SDH have received US FDA 510(k) clearance, while JLK-CTP, JLK-PWI, JLK-NCCT, JLK-FLAIR, JLK-GRE, JLK-DWI(JBS-01K), and JLK-SWI have received Japan PMDA approval. The company holds 78 regulatory approvals worldwide, including Korea's MFDS, the US FDA, Japan's PMDA, and the European CE mark.

Products & technology

  • MEDIHUB STROKE12 stroke-analysis solutions based on CT, CTP, CTA, and MRI imaging
  • JLK-DWI(JBS-01K)Cerebral infarction diagnostic aid
  • JLK-LVO / JLK-CTP / JLK-PWI / JLK-ICH / JLK-SDHStroke analysis solutions
  • JLK-CTP / JLK-PWI / JLK-NCCT / JLK-FLAIR / JLK-GRE / JLK-DWI(JBS-01K) / JLK-SWIStroke analysis solutions

Regulatory approvals

data.go.kr · openFDA

3 Innovative Medical Device designations · 2022–2025 / 64 Korean MFDS device approvals · 2018–2026 / 8 US FDA 510(k) · 2024–2026

  • InnovativeJLK-CTL2025-10-24
    Innovative Medical Device designation
  • InnovativeJLK-LVO2025-04-17
    Innovative Medical Device designation
  • InnovativeJBS-01K2022-04-26
    Innovative Medical Device designation
  • MFDSProduct name not recorded2026-09-11
    Product approval · Class 1신 26-98 호
  • MFDSProduct name not recorded2026-09-11
    Product approval · Class 1신 26-97 호
  • MFDSProduct name not recorded2026-09-07
    Product approval · Class 3허 26-27 호
  • MFDSProduct name not recorded2026-08-11
    Product approval · Class 1신 26-86 호
  • MFDSProduct name not recorded2026-08-11
    Product approval · Class 1신 26-85 호
  • MFDSProduct name not recorded2026-07-21
    Product approval · Class 1신 26-74 호
  • MFDSProduct name not recorded2026-06-30
    Product approval · Class 3허 26-19 호
  • MFDSProduct name not recorded2026-06-24
    Product approval · Class 1신 26-68 호
  • MFDSProduct name not recorded2026-06-22
    Product approval · Class 3허 26-16 호
Show 63 more
  • MFDSProduct name not recorded2026-03-27
    Product approval · Class 2인 26-4014 호
  • FDAJLK-NCCT2026-03-24
    510(k) · TraditionalRadiologyK252421
  • MFDSProduct name not recorded2026-01-15
    Product approval · Class 2인 26-4003 호
  • MFDSProduct name not recorded2026-01-12
    Product approval · Class 2인 26-4002 호
  • MFDSProduct name not recorded2025-12-02
    Product approval · Class 3허 25-14 호
  • MFDSProduct name not recorded2025-11-19
    Product approval · Class 1신 25-51 호
  • MFDSProduct name not recorded2025-09-03
    Product approval · Class 3허 25-7 호
  • MFDSProduct name not recorded2025-09-03
    Product approval · Class 3허 25-6 호
  • MFDSProduct name not recorded2025-03-17
    Product approval · Class 2인 25-4004 호
  • MFDSProduct name not recorded2025-03-12
    Product approval · Class 2인 25-4003 호
  • FDAJLK-SDH2025-03-03
    510(k) · TraditionalRadiologyK243611
  • FDAJLK-AILink2025-02-25
    510(k) · TraditionalRadiologyK250348
  • MFDSDiabetes disease risk assessment software2025-01-14
    Product approval · Class 2제허 25-26 호
  • MFDSProduct name not recorded2025-01-14
    Product approval · Class 2허 25-26 호
  • FDAJLK-ICH2025-01-03
    510(k) · TraditionalRadiologyK243363
  • MFDSMedical image, picture archiving and communication system, software, class 12024-12-10
    Product approval · Class 1제신 24-1535 호
  • MFDSProduct name not recorded2024-12-10
    Product approval · Class 1신 24-1535 호
  • FDAJLK-PWI2024-11-04
    510(k) · TraditionalRadiologyK242709
  • MFDSNeural image, analysis software2024-10-28
    Product approval · Class 2제인 24-971 호
  • MFDSProduct name not recorded2024-10-28
    Product approval · Class 2인 24-971 호
  • FDAJLK-CTP2024-10-16
    510(k) · TraditionalRadiologyK242556
  • FDAJBS-LVO2024-09-27
    510(k) · TraditionalRadiologyK241480
  • MFDSMedical image, analysis software2024-09-26
    Product approval · Class 2제인 24-887 호
  • MFDSMedical image, analysis software2024-08-20
    Product approval · Class 2제인 24-789 호
  • FDAMedihub Prostate2024-06-21
    510(k) · TraditionalRadiologyK233196
  • MFDSNeural image, computer aided detection/diagnosis software2024-05-21
    Product approval · Class 3제허 24-346 호
  • MFDSProduct name not recorded2024-05-21
    Product approval · Class 3허 24-346 호
  • MFDSNeural image, analysis softwareRevoked2024-05-03
    Product approval · Class 2제인 24-458 호
  • MFDSNeural image, analysis software2024-04-04
    Product approval · Class 2제인 24-369 호
  • MFDSProduct name not recorded2024-04-04
    Product approval · Class 2인 24-369 호
  • MFDSNeural image, analysis software2024-04-04
    Product approval · Class 2제인 24-368 호
  • MFDSProduct name not recorded2024-04-04
    Product approval · Class 2인 24-368 호
  • MFDSNeural image, computer aided detection/diagnosis software2024-03-25
    Product approval · Class 3제허 24-207 호
  • MFDSProduct name not recorded2024-03-25
    Product approval · Class 3허 24-207 호
  • MFDSOrthopaedic image, analysis software2024-03-05
    Product approval · Class 2제인 24-233 호
  • MFDSNeural image, analysis softwareRevoked2024-02-22
    Product approval · Class 2제인 24-196 호
  • MFDSNeural image, analysis softwareRevoked2024-02-22
    Product approval · Class 2제인 24-195 호
  • MFDSOther software, classⅡ, for IVDRevoked2024-02-20
    Product approval · Class 2체외 제인 24-181 호
  • MFDSNeural image, analysis software2023-11-20
    Product approval · Class 2제인 23-5262 호
  • MFDSNeural image, computer aided detection/diagnosis software2023-11-10
    Product approval · Class 3제허 23-1051 호
  • MFDSProduct name not recorded2023-11-10
    Product approval · Class 3허 23-1051 호
  • MFDSMedical image, picture archiving and communication system, software, class 1Revoked2021-12-29
    Product approval · Class 1제신 21-1721 호
  • MFDSNeural image, analysis softwareRevoked2021-08-13
    Product approval · Class 2제인 21-4702 호
  • MFDSProstate cancer image, computer aided detection /diagnosis software2021-04-07
    Product approval · Class 3제허 21-270 호
  • MFDSProduct name not recorded2021-04-07
    Product approval · Class 3허 21-270 호
  • MFDSU-healthcare gateway, class 1Revoked2020-07-06
    Product approval · Class 1제신 20-1028 호
  • MFDS의료영상분석장치소프트웨어2020-05-21
    Product approval · Class 2제인 20-4406 호
  • MFDSProduct name not recorded2020-05-21
    Product approval · Class 2인 20-4406 호
  • MFDS의료영상분석장치소프트웨어2020-05-21
    Product approval · Class 2제인 20-4405 호
  • MFDSProduct name not recordedRevoked2020-05-21
    Product approval · Class 2인 20-4405 호
  • MFDS의료영상분석장치소프트웨어Revoked2020-05-21
    Product approval · Class 2제인 20-4404 호
  • MFDS의료영상분석장치소프트웨어Revoked2020-05-20
    Product approval · Class 2제인 20-4399 호
  • MFDS의료영상분석장치소프트웨어Revoked2020-05-20
    Product approval · Class 2제인 20-4398 호
  • MFDSComputer aided diagnosis software for pathological cells or tissuesRevoked2020-02-04
    Product approval · Class 2체외 제인 20-4085 호
  • MFDS의료영상분석장치소프트웨어2020-01-13
    Product approval · Class 2제인 20-4030 호
  • MFDSProduct name not recorded2020-01-13
    Product approval · Class 2인 20-4030 호
  • MFDS의료영상전송장치소프트웨어Revoked2020-01-13
    Product approval · Class 2제인 20-4029 호
  • MFDS의료영상분석장치소프트웨어Revoked2019-10-04
    Product approval · Class 2제인 19-4829 호
  • MFDS의료영상분석장치소프트웨어Revoked2019-10-04
    Product approval · Class 2제인 19-4828 호
  • MFDS의료영상분석장치소프트웨어Revoked2019-10-02
    Product approval · Class 2제인 19-4822 호
  • MFDS의료영상분석장치소프트웨어2019-08-05
    Product approval · Class 2제인 19-4654 호
  • MFDSNeural image, computer aided detection/diagnosis software2018-08-14
    Product approval · Class 3제허 18-573 호
  • MFDSProduct name not recorded2018-08-14
    Product approval · Class 3허 18-573 호

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched
Show 63 more publications

Patents

KIPRIS · applicant-matched
Show 97 more patents

AI reads

MAA server logs · IP-verified
115
Times AI engines pulled JLK, Inc.'s records

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Times an AI needed something not yet in its index and fetched this page fresh while answering. Citations served from the index leave no trace here.

113
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Direct AI-tool queries (MCP)

Queries from users who connected this index to their own AI.

12
live 0
Last 7 days
86
live 1
Last 30 days
115
live 2
All time
  • OpenAIChatGPT-Userlive2
  • OpenAIOAI-SearchBot95
  • GoogleGoogleOther10
  • PerplexityPerplexityBot6
  • AnthropicClaudeBot2

Measured since Aug 27, 2026 · 4 AI engines · last read Oct 8, 2026

User-agent strings can be forged, so we do not count them at face value. We count only requests matched against vendor-published IP ranges, or confirmed by forward-verified reverse DNS. MCP queries are actual calls to this index's tool endpoint.

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Companies approved for the same productsMedical AI

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

DEEPNOID Inc.5 shared

Founded in 2008 and listed on KOSDAQ in 2021, DEEPNOID develops medical and industrial AI imaging solutions like DEEP:NEURO.

NEUROPHET Inc.3 shared

Founded in 2016 and listed on KOSDAQ in 2025, Neurophet develops AI brain-imaging solutions AQUA, SCALE PET, and AQUA AD.

VUNO, Inc.3 shared

Founded in 2014, VUNO provides AI-based vital-sign and medical imaging diagnostic solutions, including VUNO Med-DeepCARS and VUNO Med-Fundus AI.

Coreline Soft Co., Ltd3 shared

Founded in 2012, Coreline Soft provides the AI-based chest CT diagnostic aid suite AVIEW for lung nodules, COPD, and coronary calcification.

SGHEALTHCARE CO.,LTD.2 shared

Founded in 2009 and KOSDAQ-listed in 2024, SGHealthcare manufactures X-ray, CT, and MRI medical imaging diagnostic devices.

Sky Labs Inc.1 shared

Ring-type cuffless blood pressure monitors and a platform that turns everyday physiological signals into clinical data.

DIO Corporation1 shared

DIO Corporation, established in 1988 and listed on KOSDAQ in 2000, manufactures and sells dental implants.

BITComputer1 shared

Founded in 1985, BITComputer provides hospital information systems such as bitnixHIS and CLEMR, alongside digital healthcare and IT education businesses.

Vieworks Co., Ltd.1 shared

Vieworks, founded in 1999 and KOSDAQ-listed in 2009, develops X-ray detectors and industrial camera imaging solutions.

INFINITT Healthcare Co., Ltd.1 shared

Founded in 2002, INFINITT Healthcare provides PACS-centered medical imaging software and AI diagnostic aids across multiple clinical specialties.

SEERS Co., Ltd.1 shared

Founded in 2009, SEERS provides the wearable ECG analysis solution mobiCARE and the inpatient monitoring solution thynC, based on AI vital-sign analytics.

DreamCIS INC.1 shared

Contract research organization providing clinical trial, post-marketing surveillance, and site management services to pharma and medtech clients.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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