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Medical AIKOSDAQ 322510MAA MemberInnovative Medical Device59 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.

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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 / 48 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 recorded2026-08-11
    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
  • 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
Show 47 more
  • 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
  • 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
  • FDAJLK-PWI2024-11-04
    510(k) · TraditionalRadiologyK242709
  • MFDSNeural image, analysis software2024-10-28
    Product approval · Class 2제인 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
  • 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
  • MFDSNeural image, analysis software2024-04-04
    Product approval · Class 2제인 24-368 호
  • MFDSNeural image, computer aided detection/diagnosis software2024-03-25
    Product approval · Class 3제허 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
  • 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
  • MFDSU-healthcare gateway, class 1Revoked2020-07-06
    Product approval · Class 1제신 20-1028 호
  • MFDS의료영상분석장치소프트웨어2020-05-21
    Product approval · Class 2제인 20-4406 호
  • MFDS의료영상분석장치소프트웨어2020-05-21
    Product approval · Class 2제인 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
  • 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
Not yet compiled: business overview · R&D. Send us materials and we will add them

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.

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.

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.

SGHEALTHCARE CO.,LTD.2 shared

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

BITComputer1 shared

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

CU MEDICAL SYSTEMS Inc.1 shared

Founded in 2001 and KOSDAQ-listed in 2011, CU Medical Systems makes AEDs and other emergency medical devices.

DIO Corporation1 shared

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

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.

MEZOO Co., Ltd.1 shared

KOSDAQ-listed medical device company developing the HiCardi wearable patch-type patient monitor.

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.

Vieworks Co., Ltd.1 shared

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

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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