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Medical AIKOSDAQ 071200144 approvals

INFINITT Healthcare Co., Ltd.

Official website

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

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2002 and listed on KOSDAQ in 2010, INFINITT Healthcare is a medical software company. Centered on its Picture Archiving and Communication System (PACS), it offers specialty-specific PACS for cardiology, dentistry, and radiation oncology, the radiation dose management solution INFINITT DoseM, and the AI-based colorectal cancer/polyp detection aid INFINITT Smart Endo. Its products are supplied to about 6,300 medical institutions in 55 countries through its Korean headquarters and eight overseas subsidiaries; it was ranked No. 1 in the small/mid-size hospital PACS segment 12 times in KLAS reports from 2009 to 2019, and INFINITT Smart Endo was designated an 'evaluation-deferred new health technology' by NECA in December 2025.

Products & technology

  • INFINITT PACSRadiology picture archiving and communication system
  • INFINITT DoseMRadiation dose management system
  • INFINITT Cardiology PACSCardiology PACS
  • INFINITT Dental PACSDental PACS
  • INFINITT RT solutionRadiation oncology PACS
  • INFINITT Digital Pathology SolutionDigital pathology solution
  • INFINITT Mammo PACSMammography PACS
  • INFINITT Healthcare PlatformVendor Neutral Archive for integrated medical data management
  • INFINITT Smart EndoAI-based colorectal cancer and polyp detection aid
  • INFINITT AI GatekeeperCoronary artery disease screening aid

Regulatory approvals

data.go.kr · openFDA

140 Korean MFDS device approvals · 2001–2024 / 4 US FDA 510(k) · 2017–2025

  • FDAINFINITT DPS2025-12-09
    510(k) · TraditionalPathologyK243449
  • MFDSU-healthcare gateway software, class 12024-09-30
    Product approval · Class 1제신 24-1200 호
  • MFDSProduct name not recorded2024-09-30
    Product approval · Class 1신 24-1200 호
  • MFDSGastric cancer image, computer aided detection/ diagnosis software2024-09-03
    Product approval · Class 3제허 24-600 호
  • MFDSProduct name not recorded2024-09-03
    Product approval · Class 3허 24-600 호
  • MFDSCardiovascular risk assessment software2023-12-13
    Product approval · Class 3제허 23-1135 호
  • MFDSCardiovascular image, analysis softwareRevoked2022-06-13
    Product approval · Class 2수인 22-4305 호
  • FDAXelis Dental 2.02020-04-14
    510(k) · TraditionalRadiologyK193369
  • MFDSEndoscopic image, computer aided detection/ diagnosis software2020-02-25
    Product approval · Class 2제인 20-4154 호
  • FDAInfinitt RT PACS2020-02-13
    510(k) · TraditionalRadiologyK193498
  • MFDSDental image, Picture archiving and communication system, software, class 22019-11-01
    Product approval · Class 2제인 19-4892 호
  • MFDSMedical image, analysis softwareRevoked2019-07-22
    Product approval · Class 2수인 19-4490 호
Show 68 more
  • MFDSCardiovascular image, analysis softwareRevoked2019-07-22
    Product approval · Class 2수인 19-4491 호
  • MFDSMedical image, picture archiving and communication system, software, class 22018-12-06
    Product approval · Class 2제인 18-5025 호
  • MFDSProduct name not recorded2018-12-06
    Product approval · Class 2인 18-5025 호
  • MFDSComputer aided diagnosis software for pathological cells or tissues2018-10-30
    Product approval · Class 2체외 제인 18-4883 호
  • MFDSMedical image, picture archiving and communication system, software, class 22018-03-16
    Product approval · Class 2제인 18-4202 호
  • FDAInfinitt PACS 7.02017-10-27
    510(k) · TraditionalRadiologyK172803
  • MFDSMedical image, picture archiving and communication system, software, class 2Revoked2017-01-12
    Product approval · Class 2제인 17-4032 호
  • MFDSMedical image, picture archiving and communication system, software, class 2Revoked2017-01-12
    Product approval · Class 2제인 17-4033 호
  • MFDSMedical image, picture archiving and communication system, software, class 22016-04-07
    Product approval · Class 2제인 16-4309 호
  • MFDSProduct name not recorded2016-04-07
    Product approval · Class 2인 16-4309 호
  • MFDSMedical image, picture archiving and communication system, software, class 22016-01-29
    Product approval · Class 2제인 16-4088 호
  • MFDSMedical image, picture archiving and communication system, software, class 2Revoked2014-04-02
    Product approval · Class 2제인 14-780 호
  • MFDSMedical image, picture archiving and communication system, software, class 2Revoked2014-04-01
    Product approval · Class 2제인 14-773 호
  • MFDSMedical image, picture archiving and communication system, software, class 22012-01-18
    Product approval · Class 2제인 12-91 호
  • MFDSMedical image, picture archiving and communication system, software, class 22011-09-08
    Product approval · Class 2제인 11-989 호
  • MFDSDental image, Picture archiving and communication system, software, class 22011-08-29
    Product approval · Class 2제인 11-945 호
  • MFDSMedical image, analysis software2011-02-11
    Product approval · Class 2제인 11-129 호
  • MFDSMedical image, picture archiving and communication system, software, class 22010-12-08
    Product approval · Class 2제인 10-1276 호
  • MFDSMedical image, picture archiving and communication system, software, class 22007-04-06
    Product approval · Class 2제인 07-185 호
  • MFDSTelemetry system transmitter, analysisRevoked2006-05-17
    Product approval · Class 2제허 06-347 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2006-03-17
    Product approval · Class 2제허 06-192 호
  • MFDSMedical image, picture archiving and communication system, software, class 22005-09-26
    Product approval · Class 2제인 05-772 호
  • MFDSTelemetry system transmitter, analysisRevoked2004-10-14
    Product approval · Class 2제허 04-1040 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-10-02
    Product approval · Class 2제허 04-1011 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-09-20
    Product approval · Class 2제허 04-986 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-09-20
    Product approval · Class 2제허 04-987 호
  • MFDSMedical image, picture archiving and communication system, software, class 22004-09-20
    Product approval · Class 2제인 04-988 호
  • MFDSProduct name not recorded2004-09-20
    Product approval · Class 2인 04-988 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-09-18
    Product approval · Class 2제허 04-979 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-09-17
    Product approval · Class 2제허 04-978 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-09-10
    Product approval · Class 2제허 04-936 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-09-10
    Product approval · Class 2제허 04-937 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-09-06
    Product approval · Class 2제허 04-928 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-09-06
    Product approval · Class 2제허 04-929 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-08-19
    Product approval · Class 2제허 04-859 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-08-19
    Product approval · Class 2제허 04-860 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-08-19
    Product approval · Class 2제허 04-861 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-08-10
    Product approval · Class 2제허 04-829 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-08-10
    Product approval · Class 2제허 04-830 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-07-30
    Product approval · Class 2제허 04-812 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-07-30
    Product approval · Class 2제허 04-813 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-07-28
    Product approval · Class 2제허 04-805 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-07-28
    Product approval · Class 2제허 04-806 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-07-19
    Product approval · Class 2제허 04-782 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-07-19
    Product approval · Class 2제허 04-783 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-07-14
    Product approval · Class 2제허 04-764 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-05-28
    Product approval · Class 2제허 04-537 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-05-28
    Product approval · Class 2제허 04-538 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-05-28
    Product approval · Class 2제허 04-539 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-05-27
    Product approval · Class 2제허 04-528 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-05-08
    Product approval · Class 2제허 04-471 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-05-08
    Product approval · Class 2제허 04-472 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-04-30
    Product approval · Class 2제허 04-441 호
  • MFDSTelemetry system transmitter, analysisRevoked2004-04-26
    Product approval · Class 2제허 04-423 호
  • MFDSTelemetry system transmitter, analysisRevoked2004-04-26
    Product approval · Class 2제허 04-424 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-04-26
    Product approval · Class 2제허 04-425 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-04-22
    Product approval · Class 2제허 04-400 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-04-12
    Product approval · Class 2제허 04-366 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-02-25
    Product approval · Class 2제허 04-190 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-02-25
    Product approval · Class 2제허 04-191 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-02-23
    Product approval · Class 2제허 04-182 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-02-18
    Product approval · Class 2제허 04-164 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-01-27
    Product approval · Class 2제허 04-92 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-01-27
    Product approval · Class 2제허 04-93 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-01-05
    Product approval · Class 2제허 04-8 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2004-01-05
    Product approval · Class 2제허 04-9 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2003-12-30
    Product approval · Class 2제허 03-1214 호
  • MFDS의료용영상처리용장치소프트웨어Revoked2003-12-30
    Product approval · Class 2제허 03-1215 호

Showing the 80 most recent of 144 records.

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.

RAYENCE CO.,LTD.3 shared

KOSDAQ-listed X-ray imaging solution company with a full lineup of medical, dental, veterinary, and industrial X-ray detectors.

ABION Inc.2 shared

KOSDAQ-listed biotech developing biomarker-driven targeted cancer therapies including lead candidate Vabametkib (ABN401).

BITComputer2 shared

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

DEEPNOID Inc.2 shared

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

DRTECH Corporation2 shared

KOSDAQ-listed digital diagnostic imaging company providing X-ray systems, detectors, and components.

Vieworks Co., Ltd.2 shared

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

GENORAY Co., LTD.1 shared

Genoray, founded in 2001 and KOSDAQ-listed in 2018, manufactures medical and dental X-ray imaging diagnostic devices.

i-SENS, Inc.1 shared

Founded in 2000 and KOSDAQ-listed in 2013, i-SENS makes blood glucose monitors and point-of-care testing devices.

JLK, Inc.1 shared

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

SHINHUNG CO.,LTD1 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

ValueAddedTechnologyCo.,Ltd.1 shared

Founded in 1992 and KOSDAQ-listed in 2006, VATECH manufactures dental digital X-ray and CT imaging diagnostic devices.

VUNO, Inc.1 shared

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

Sources and updates

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

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