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Medical DevicesKOSDAQ 26369057 approvals

DRGEM CORPORATION

Official website

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

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2003 and listed on KOSDAQ in 2018, DRGEM is a medical device company specializing in diagnostic X-ray imaging systems. It designs and manufactures both analog and digital X-ray imaging systems along with core components such as generators, tubes, collimators, and imaging software, offering stationary product lines including GXR-S/SD, GXR-ES, DIAMOND, and VXR, and mobile product lines including TOPAZ, JADE, PROMO, and RAYMO. It sells through about 250 dealers in roughly 120 countries worldwide.

Products & technology

  • GeneratorCore X-ray generation component (standard, C-type, U-type)
  • Stationary digital X-ray system (GXR-S/SD, GXR-ES, DIAMOND, VXR Series)Stationary diagnostic X-ray system for hospitals and clinics
  • Mobile digital X-ray system (TOPAZ, JADE, PROMO, RAYMO)Mobile diagnostic X-ray system for hospitals and clinics

Regulatory approvals

data.go.kr · openFDA

44 Korean MFDS device approvals · 2008–2026 / 13 US FDA 510(k) · 2019–2026

  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2026-07-01
    Product approval · Class 2제인 26-4592 호
  • MFDSUltrasound imaging system, general-purpose2026-06-18
    Product approval · Class 2제인 26-4541 호
  • MFDSUltrasound imaging system, general-purpose2026-06-18
    Product approval · Class 2제인 26-4540 호
  • FDARAYMO Mobile X-ray System (Model: RAYMO)2026-05-14
    510(k) · TraditionalRadiologyK260085
  • MFDSUltrasound imaging system, general-purpose2026-03-03
    Product approval · Class 2제인 26-4186 호
  • MFDSUltrasound imaging system, general-purpose2026-01-07
    Product approval · Class 2제인 26-4013 호
  • MFDSX-ray system, diagnostic, mobile, digital2025-12-26
    Product approval · Class 2제인 25-5202 호
  • FDAPROMO2025-08-22
    510(k) · TraditionalRadiologyK251443
  • MFDSX-ray system, diagnostic, mobile, digital2025-03-13
    Product approval · Class 2제인 25-4197 호
  • FDAGXR-Series Diagnostic X-Ray System2025-01-07
    510(k) · TraditionalRadiologyK242019
  • FDATOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)2024-12-16
    510(k) · TraditionalRadiologyK242015
  • MFDSMedical image, picture archiving and communication system, software, class 22024-06-25
    Product approval · Class 2제인 24-626 호
Show 45 more
  • FDAGXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)2023-09-19
    510(k) · TraditionalRadiologyK232178
  • MFDSTable, x-ray system, diagnostic, electrically-powered2023-05-09
    Product approval · Class 1제신 23-783 호
  • MFDSX-ray system, general-purpose, analogue2021-09-09
    Product approval · Class 2제인 21-4790 호
  • MFDSX-ray system, general-purpose, analogue2021-01-29
    Product approval · Class 2제인 21-4079 호
  • FDAGXR-Series Diagnostic X-Ray System2020-09-24
    510(k) · SpecialRadiologyK202572
  • FDADIAMOND-5A/6A/8A2020-09-10
    510(k) · SpecialRadiologyK202156
  • FDATOPAZ Mobile DR System2020-05-19
    510(k) · SpecialRadiologyK201124
  • MFDSX-ray system, general-purpose, analogue2020-03-19
    Product approval · Class 2제인 20-4215 호
  • MFDSMedical image, analog to digital transform, DR, CRRevoked2020-01-14
    Product approval · Class 2수인 20-4039 호
  • MFDSMedical image, analog to digital transform, DR, CRRevoked2020-01-13
    Product approval · Class 2수인 20-4033 호
  • FDADIAMOND-5A/6A/8A2019-10-01
    510(k) · SpecialRadiologyK192453
  • FDAGXR-Series Diagnostic X-Ray System2019-09-26
    510(k) · TraditionalRadiologyK192364
  • FDATopaz Mobile DR System2019-05-15
    510(k) · TraditionalRadiologyK183292
  • FDARADMAX Digital Imaging Software2019-03-08
    510(k) · TraditionalRadiologyK182537
  • FDAJADE Mobile X-Ray2019-02-05
    510(k) · TraditionalRadiologyK183388
  • MFDSX-ray grid, movingRevoked2018-10-30
    Product approval · Class 1수신 18-2370 호
  • MFDSX-ray grid, movingRevoked2018-10-29
    Product approval · Class 1수신 18-2356 호
  • MFDSX-ray grid, movingRevoked2018-10-29
    Product approval · Class 1수신 18-2355 호
  • MFDSX-ray grid, movingRevoked2018-10-29
    Product approval · Class 1수신 18-2354 호
  • MFDSX-ray grid, movingRevoked2018-10-29
    Product approval · Class 1수신 18-2352 호
  • MFDSX-ray grid, movingRevoked2018-10-29
    Product approval · Class 1수신 18-2351 호
  • MFDSX-ray grid, movingRevoked2018-10-29
    Product approval · Class 1수신 18-2350 호
  • MFDSX-ray grid, movingRevoked2018-10-26
    Product approval · Class 1수신 18-2339 호
  • MFDSX-ray system, diagnostic, mobile, analogue2018-07-11
    Product approval · Class 2제인 18-4544 호
  • MFDSX-ray system, diagnostic, mobile, analogue2018-01-26
    Product approval · Class 2제인 18-4058 호
  • MFDSX-ray system, diagnostic, mobile, analogue2014-12-09
    Product approval · Class 2제인 14-2917 호
  • MFDSX-ray system, diagnostic, mobile, digital2014-11-27
    Product approval · Class 2제인 14-2613 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2014-04-29
    Product approval · Class 2제인 14-962 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2014-04-29
    Product approval · Class 2제인 14-963 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2014-04-29
    Product approval · Class 2제인 14-964 호
  • MFDSX-ray system, general-purpose, analogue2014-03-14
    Product approval · Class 2제인 14-632 호
  • MFDSX-ray system, diagnostic, general-purpose, digitalRevoked2012-08-07
    Product approval · Class 2제인 12-1030 호
  • MFDSX-ray system, diagnostic, general-purpose, digitalRevoked2012-08-06
    Product approval · Class 2제인 12-1023 호
  • MFDSMedical image, analog to digital transform, DR, CR2012-08-06
    Product approval · Class 2제인 12-1024 호
  • MFDSX-ray system, general-purpose, analogue2010-12-20
    Product approval · Class 2제인 10-1303 호
  • MFDSX-ray system, general-purpose, analogue2010-12-20
    Product approval · Class 2제인 10-1302 호
  • MFDSX-ray system, general-purpose, analogueRevoked2010-12-20
    Product approval · Class 2제인 10-1301 호
  • MFDSX-ray system, general-purpose, analogueRevoked2010-12-20
    Product approval · Class 2제인 10-1300 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2009-12-23
    Product approval · Class 2제인 09-1070 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2009-12-23
    Product approval · Class 2제인 09-1071 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2009-12-23
    Product approval · Class 2제인 09-1069 호
  • MFDSX-ray system, general-purpose, analogueRevoked2009-01-30
    Product approval · Class 2제인 09-68 호
  • MFDSX-ray system, general-purpose, analogueRevoked2009-01-30
    Product approval · Class 2제인 09-69 호
  • MFDSX-ray system, general-purpose, analogueRevoked2008-03-18
    Product approval · Class 2제인 08-156 호
  • MFDSX-ray system, general-purpose, analogueRevoked2008-03-18
    Product approval · Class 2제인 08-155 호
Not yet compiled: business overview · R&D. Send us materials and we will add them

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 Corporation10 shared

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

SGHEALTHCARE CO.,LTD.6 shared

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

JW PHARMACEUTICAL3 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.

Vieworks Co., Ltd.3 shared

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

GENORAY Co., LTD.2 shared

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

RAYENCE CO.,LTD.2 shared

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

DongKook Life Science Co., Ltd.1 shared

Founded in 2017 and KOSDAQ-listed in 2025, DongKook Life Science makes contrast agent products and distributes medical devices.

Finemedix Co., Ltd.1 shared

KOSDAQ-listed medical device company producing ESD/EMR endoscopic devices such as ClearCut Knife and Clear-Jet Injector.

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.

JPI Healthcare Co., Ltd.1 shared

JPI Healthcare, founded 1980, makes X-ray imaging device components and equipment, listed on KOSDAQ in August 2025.

SELVAS Healthcare, Inc.1 shared

SELVAS Healthcare operates the ACCUNIQ medical diagnostic device brand and the HIMS assistive technology device brand.

JETEMA Co.,Ltd.90

Founded 2009, listed on KOSDAQ in 2019, JETEMA develops hyaluronic acid fillers, botulinum toxin biopharmaceuticals, and lifting threads.

Sources and updates

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

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