Medical AI Alliance
← Company Index
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.

As of 2026-10-10, DRGEM CORPORATION has 44 Korean MFDS device approvals, 13 US FDA clearances/approvals on record (counted by the MAA Company Index from its own matching of public databases).

Price

Change

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

Key disclosures

KRX KIND via OpenDART

Patents

KIPRIS · applicant-matched
Show 35 more patents

AI reads

MAA server logs · IP-verified
99
Times AI engines pulled DRGEM CORPORATION's records

Pulled records become part of each AI's index and keep feeding its answers. When an AI cites from that index, nothing reaches our server — so actual citations are uncounted here and exceed this number.

3
Fetched fresh mid-answer

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.

96
Index crawls

Collected as raw material for future answers.

0
Direct AI-tool queries (MCP)

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

12
live 1
Last 7 days
69
live 2
Last 30 days
99
live 3
All time
  • OpenAIChatGPT-Userlive3
  • OpenAIOAI-SearchBot69
  • GoogleGoogleOther17
  • PerplexityPerplexityBot8
  • AnthropicClaudeBot2

Measured since Aug 27, 2026 · 4 AI engines · last read Oct 9, 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.

Connect this index to your AI tool →

Connect this company index directly to your AI

Connect it to ChatGPT or Claude, and your AI queries the full record — profiles, financials, stock data, regulatory approvals, clinical trials, publications and patents — for DRGEM CORPORATION and every listed Korean medical, bio and AI company.

How to connect (MCP)
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.

Vieworks Co., Ltd.3 shared

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

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.

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.

GENORAY Co., LTD.2 shared

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

MEKICS Co., Ltd1 shared

KOSDAQ-listed critical-care medical device company manufacturing ventilators, the OmniOx respiratory therapy device series, and patient monitors.

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.

JPI Healthcare Co., Ltd.1 shared

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

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.

SELVAS Healthcare, Inc.1 shared

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

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.

Request a correction or addition