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Medical DevicesKOSDAQ 39812061 approvals

SGHEALTHCARE CO.,LTD.

Official website

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

As of 2026-10-10, SGHEALTHCARE CO.,LTD. has 58 Korean MFDS device approvals, 3 US FDA clearances/approvals on record (counted by the MAA Company Index from its own matching of public databases).

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Business overview

Source: DART corporate disclosure

Founded in 2009 and listed on KOSDAQ in 2024, SGHealthcare is a medical imaging diagnostic device company making X-ray, C-arm, CT, MRI, and ultrasound systems. It manufactures the JUMONG General X-ray system, the Garion C-arm, the DOMINUS CT scanner, and the INVICTUS MRI system, and developed the deep-learning-based MRI acceleration software IAI (Innovative AI) through its subsidiary Minttlabs. It established Minttlabs in 2021 and completed development of the IAI software in 2022, and in September 2025 it set up a local subsidiary in Almaty, Kazakhstan, and is preparing to open the first branch of its imaging-center brand, Seoul Medical Center.

Products & technology

  • JUMONG GeneralAnalog and digital X-ray imaging diagnostics
  • GarionC-arm diagnostic radiation and mobile fluoroscopy
  • Jumong RetroDigital upgrade for analog X-ray equipment
  • DOMINUSComputed tomography (CT)
  • INVICTUSMagnetic resonance imaging (MRI)
  • Ultrasound diagnostic deviceUltrasound imaging diagnostics
  • IAI (Innovative AI)Deep-learning-based MRI acceleration solution

Regulatory approvals

data.go.kr · openFDA

58 Korean MFDS device approvals · 2011–2025 / 3 US FDA 510(k) · 2015–2023

  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2025-12-02
    Product approval · Class 2제인 25-5122 호
  • MFDSFilm processor for medical use, laser2025-08-27
    Product approval · Class 1수신 25-1862 호
  • MFDSMedical image, picture archiving and communication system, software, class 12024-05-28
    Product approval · Class 1제신 24-657 호
  • MFDSProduct name not recorded2024-05-28
    Product approval · Class 1신 24-657 호
  • MFDSDental x-ray system, panoramic/tomographic, digital2024-02-23
    Product approval · Class 2제인 24-208 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2023-05-30
    Product approval · Class 2제인 23-619 호
  • MFDSMRI system, full-body, superconducting magnetRevoked2023-03-28
    Product approval · Class 2수인 23-4441 호
  • FDAJumong General2023-02-23
    510(k) · SpecialRadiologyK230241
  • FDAGarion Image-Intensified Fluoroscopic X-Ray System, Mobile2022-10-06
    510(k) · TraditionalRadiologyK222080
  • MFDSMedical image, picture archiving and communication system, software, class 12022-09-01
    Product approval · Class 1제신 22-1232 호
  • MFDSProduct name not recorded2022-09-01
    Product approval · Class 1신 22-1232 호
  • MFDSX-ray system, general-purpose, analogue2022-06-27
    Product approval · Class 2제인 22-4481 호
Show 49 more
  • MFDSBone absorptiometric x-ray system, dual-energyRevoked2022-03-15
    Product approval · Class 3제허 22-178 호
  • MFDSMRI system, full-body, superconducting magnet2022-03-15
    Product approval · Class 2제인 22-4203 호
  • MFDSMedical image, analog to digital transform, DR, CR2021-09-02
    Product approval · Class 2제인 21-4766 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digitalRevoked2021-07-16
    Product approval · Class 2제인 21-612 호
  • MFDSCT system, full-body2020-12-14
    Product approval · Class 2제인 20-5106 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digitalRevoked2020-10-13
    Product approval · Class 2제인 20-879 호
  • MFDSCT system, full-body2019-08-21
    Product approval · Class 2제인 19-4703 호
  • MFDSMedical image, analog to digital transform, DR, CR2019-06-24
    Product approval · Class 2제인 19-4506 호
  • MFDSCT system, full-body2018-12-27
    Product approval · Class 2제인 18-5084 호
  • MFDSMedical image, analog to digital transform, DR, CR2018-11-29
    Product approval · Class 2제인 18-4999 호
  • MFDSCT system, full-body2018-07-02
    Product approval · Class 2제인 18-4514 호
  • MFDSX-ray system, general-purpose, analogue2017-06-28
    Product approval · Class 2제인 17-4510 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digitalRevoked2017-03-23
    Product approval · Class 3제허 17-212 호
  • MFDSMRI system, full-body, superconducting magnet2017-02-22
    Product approval · Class 2제인 17-4109 호
  • MFDSMRI system, full-body, permanent magnetRevoked2017-02-10
    Product approval · Class 2제인 17-4090 호
  • MFDSUltrasound imaging system, general-purpose2017-01-18
    Product approval · Class 2제인 17-4043 호
  • MFDSMRI system, full-body, permanent magnet2017-01-16
    Product approval · Class 2제인 17-4039 호
  • MFDSX-ray system, general-purpose, analogue2016-09-26
    Product approval · Class 2제인 16-4761 호
  • MFDSMedical image, analog to digital transform, DR, CR2016-05-17
    Product approval · Class 2제인 16-4404 호
  • MFDSX-ray system, general-purpose, analogue2016-04-04
    Product approval · Class 2제인 16-4295 호
  • MFDSX-ray system, general-purpose, analogueRevoked2016-02-29
    Product approval · Class 2제인 16-4175 호
  • MFDSX-ray system, diagnostic, mobile, digital2016-02-04
    Product approval · Class 2제인 16-4112 호
  • MFDSMedical image, analog to digital transform, DR, CR2016-01-11
    Product approval · Class 2제인 16-4027 호
  • MFDSX-ray system, general-purpose, analogue2016-01-05
    Product approval · Class 2제인 16-4012 호
  • MFDSUltrasound imaging system, general-purpose2015-12-28
    Product approval · Class 2제인 15-4422 호
  • MFDSUltrasound imaging system, general-purposeRevoked2015-09-16
    Product approval · Class 2수인 15-4082 호
  • FDAJumong Series2015-05-08
    510(k) · TraditionalRadiologyK150816
  • MFDSMedical image, analog to digital transform, DR, CRRevoked2015-04-06
    Product approval · Class 2제허 15-478 호
  • MFDSUltrasound imaging system, general-purposeRevoked2014-10-15
    Product approval · Class 2제허 14-1826 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digitalRevoked2014-07-04
    Product approval · Class 3제허 14-1274 호
  • MFDSFluoroscopic x-ray system, general-purpose, stationary, digitalRevoked2014-04-18
    Product approval · Class 3제허 14-904 호
  • MFDSUltrasound imaging system, general-purposeRevoked2014-04-16
    Product approval · Class 2제허 14-884 호
  • MFDSUltrasound imaging system, general-purposeRevoked2014-02-28
    Product approval · Class 2제허 14-514 호
  • MFDSUltrasound imaging system, general-purposeRevoked2014-02-28
    Product approval · Class 2제허 14-515 호
  • MFDSUltrasound imaging system, general-purposeRevoked2014-02-26
    Product approval · Class 2제허 14-484 호
  • MFDSMRI system, full-body, permanent magnetRevoked2013-12-19
    Product approval · Class 2제허 13-2175 호
  • MFDSUltrasound imaging system, general-purposeRevoked2013-07-03
    Product approval · Class 2제허 13-1152 호
  • MFDSUltrasound imaging system, general-purposeRevoked2013-07-03
    Product approval · Class 2제허 13-1158 호
  • MFDSUltrasound imaging system, general-purposeRevoked2013-07-02
    Product approval · Class 2제허 13-1144 호
  • MFDSUltrasound imaging system, general-purposeRevoked2013-07-02
    Product approval · Class 2제허 13-1145 호
  • MFDSX-ray system, diagnostic, mobile, digitalRevoked2013-06-25
    Product approval · Class 2제허 13-1099 호
  • MFDSMedical image, analog to digital transform, DR, CR2013-06-25
    Product approval · Class 2제인 13-1095 호
  • MFDSX-ray system, general-purpose, analogueRevoked2013-06-19
    Product approval · Class 2제허 13-1061 호
  • MFDSX-ray system, diagnostic, mobile, analogueRevoked2012-10-31
    Product approval · Class 2제허 12-1384 호
  • MFDSX-ray system, diagnostic, mobile, analogueRevoked2012-10-31
    Product approval · Class 2제허 12-1385 호
  • MFDSMammographic x-ray system, stationary, analogueRevoked2012-07-19
    Product approval · Class 2제허 12-940 호
  • MFDSMammographic x-ray system, stationary, analogueRevoked2012-07-18
    Product approval · Class 2제허 12-936 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2012-06-04
    Product approval · Class 2제인 12-713 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2011-10-28
    Product approval · Class 2제인 11-1196 호

R&D and key agreements

Source: DART corporate disclosure

IAI(Innovative AI) MRI 가속 소프트웨어 · 개발완료(2022) · Established subsidiary Minttlabs in 2021 to develop AI software for medical devices, completed in 2022

Key disclosures

KRX KIND via OpenDART
Show 5 more events

Patents

KIPRIS · applicant-matched
Show 1 more patents

AI reads

MAA server logs · IP-verified
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Companies approved for the same productsMedical Devices

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

DRTECH Corporation8 shared

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

DRGEM CORPORATION6 shared

KOSDAQ-listed manufacturer of diagnostic X-ray imaging systems and core components such as generators and tubes.

Vieworks Co., Ltd.4 shared

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

JW PHARMACEUTICAL4 shared

Founded in 1945, JW Pharmaceutical holds an original drug pipeline including Rivalo and Hemlibra, plus the IV nutrition product Winuf and OTC brand Hwakol.

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.

GENORAY Co., LTD.3 shared

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

WonIk Co.,LTD2 shared

WonIk, founded in 1983 and KOSDAQ-listed in 1997, operates pressure sensor, dermo-cosmetic, and medical device distribution businesses.

JLK, Inc.2 shared

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

DEEPNOID Inc.2 shared

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

REMEDI Inc.1 shared

Founded in 2012 and listed on KOSDAQ in 2026, REMEDI develops portable X-ray imaging devices based on its low-dose, miniaturized X-ray technology.

ValueAddedTechnologyCo.,Ltd.1 shared

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

DONG-A ST CO.,LTD1 shared

Dong-A ST, spun off from Dong-A Socio Holdings in 2013 and KOSPI-listed, makes prescription drugs like Growtropin, Stillen, and Bacchus.

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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