DRGEM CORPORATION
KOSDAQ-listed manufacturer of diagnostic X-ray imaging systems and core components such as generators and tubes.
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Business overview
Source: DART corporate disclosureFounded 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 · openFDA44 Korean MFDS device approvals · 2008–2026 / 13 US FDA 510(k) · 2019–2026
- MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2026-07-01Product approval · Class 2제인 26-4592 호
- MFDSUltrasound imaging system, general-purpose2026-06-18Product approval · Class 2제인 26-4541 호
- MFDSUltrasound imaging system, general-purpose2026-06-18Product approval · Class 2제인 26-4540 호
- FDARAYMO Mobile X-ray System (Model: RAYMO)2026-05-14
- MFDSUltrasound imaging system, general-purpose2026-03-03Product approval · Class 2제인 26-4186 호
- MFDSUltrasound imaging system, general-purpose2026-01-07Product approval · Class 2제인 26-4013 호
- MFDSX-ray system, diagnostic, mobile, digital2025-12-26Product approval · Class 2제인 25-5202 호
- FDAPROMO2025-08-22
- MFDSX-ray system, diagnostic, mobile, digital2025-03-13Product approval · Class 2제인 25-4197 호
- FDAGXR-Series Diagnostic X-Ray System2025-01-07
- FDATOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)2024-12-16
- MFDSMedical image, picture archiving and communication system, software, class 22024-06-25Product 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
- MFDSTable, x-ray system, diagnostic, electrically-powered2023-05-09Product approval · Class 1제신 23-783 호
- MFDSX-ray system, general-purpose, analogue2021-09-09Product approval · Class 2제인 21-4790 호
- MFDSX-ray system, general-purpose, analogue2021-01-29Product approval · Class 2제인 21-4079 호
- FDAGXR-Series Diagnostic X-Ray System2020-09-24
- FDADIAMOND-5A/6A/8A2020-09-10
- FDATOPAZ Mobile DR System2020-05-19
- MFDSX-ray system, general-purpose, analogue2020-03-19Product approval · Class 2제인 20-4215 호
- MFDSMedical image, analog to digital transform, DR, CRRevoked2020-01-14Product approval · Class 2수인 20-4039 호
- MFDSMedical image, analog to digital transform, DR, CRRevoked2020-01-13Product approval · Class 2수인 20-4033 호
- FDADIAMOND-5A/6A/8A2019-10-01
- FDAGXR-Series Diagnostic X-Ray System2019-09-26
- FDATopaz Mobile DR System2019-05-15
- FDARADMAX Digital Imaging Software2019-03-08
- FDAJADE Mobile X-Ray2019-02-05
- MFDSX-ray grid, movingRevoked2018-10-30Product approval · Class 1수신 18-2370 호
- MFDSX-ray grid, movingRevoked2018-10-29Product approval · Class 1수신 18-2356 호
- MFDSX-ray grid, movingRevoked2018-10-29Product approval · Class 1수신 18-2355 호
- MFDSX-ray grid, movingRevoked2018-10-29Product approval · Class 1수신 18-2354 호
- MFDSX-ray grid, movingRevoked2018-10-29Product approval · Class 1수신 18-2352 호
- MFDSX-ray grid, movingRevoked2018-10-29Product approval · Class 1수신 18-2351 호
- MFDSX-ray grid, movingRevoked2018-10-29Product approval · Class 1수신 18-2350 호
- MFDSX-ray grid, movingRevoked2018-10-26Product approval · Class 1수신 18-2339 호
- MFDSX-ray system, diagnostic, mobile, analogue2018-07-11Product approval · Class 2제인 18-4544 호
- MFDSX-ray system, diagnostic, mobile, analogue2018-01-26Product approval · Class 2제인 18-4058 호
- MFDSX-ray system, diagnostic, mobile, analogue2014-12-09Product approval · Class 2제인 14-2917 호
- MFDSX-ray system, diagnostic, mobile, digital2014-11-27Product approval · Class 2제인 14-2613 호
- MFDSX-ray system, diagnostic, general-purpose, digital2014-04-29Product approval · Class 2제인 14-962 호
- MFDSX-ray system, diagnostic, general-purpose, digital2014-04-29Product approval · Class 2제인 14-963 호
- MFDSX-ray system, diagnostic, general-purpose, digital2014-04-29Product approval · Class 2제인 14-964 호
- MFDSX-ray system, general-purpose, analogue2014-03-14Product approval · Class 2제인 14-632 호
- MFDSX-ray system, diagnostic, general-purpose, digitalRevoked2012-08-07Product approval · Class 2제인 12-1030 호
- MFDSX-ray system, diagnostic, general-purpose, digitalRevoked2012-08-06Product approval · Class 2제인 12-1023 호
- MFDSMedical image, analog to digital transform, DR, CR2012-08-06Product approval · Class 2제인 12-1024 호
- MFDSX-ray system, general-purpose, analogue2010-12-20Product approval · Class 2제인 10-1303 호
- MFDSX-ray system, general-purpose, analogue2010-12-20Product approval · Class 2제인 10-1302 호
- MFDSX-ray system, general-purpose, analogueRevoked2010-12-20Product approval · Class 2제인 10-1301 호
- MFDSX-ray system, general-purpose, analogueRevoked2010-12-20Product approval · Class 2제인 10-1300 호
- MFDSX-ray system, diagnostic, general-purpose, digital2009-12-23Product approval · Class 2제인 09-1070 호
- MFDSX-ray system, diagnostic, general-purpose, digital2009-12-23Product approval · Class 2제인 09-1071 호
- MFDSX-ray system, diagnostic, general-purpose, digital2009-12-23Product approval · Class 2제인 09-1069 호
- MFDSX-ray system, general-purpose, analogueRevoked2009-01-30Product approval · Class 2제인 09-68 호
- MFDSX-ray system, general-purpose, analogueRevoked2009-01-30Product approval · Class 2제인 09-69 호
- MFDSX-ray system, general-purpose, analogueRevoked2008-03-18Product approval · Class 2제인 08-156 호
- MFDSX-ray system, general-purpose, analogueRevoked2008-03-18Product approval · Class 2제인 08-155 호
Companies approved for the same productsMedical Devices
Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.
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JPI Healthcare, founded 1980, makes X-ray imaging device components and equipment, listed on KOSDAQ in August 2025.
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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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