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Medical DevicesKOSDAQ 21468093 approvals

DRTECH Corporation

Official website

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

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Business overview

Source: DART corporate disclosure

Founded and listed on KOSDAQ in 2015, DRTECH is a company specializing in digital diagnostic imaging solutions. It offers the AIDIA Nex and AIDIA Volve mammography systems, the AIDIA LUXE 3D breast cancer diagnostic system, the EXTRON surgical C-arm X-ray system, the Xero dental intraoral X-ray system, the DXG human X-ray generator, and the EXSYS DEXi human X-ray system. Overseas sales account for about 80% of revenue, and it holds more than 30% share of the U.S. veterinary X-ray detector market, ranking No.1.

Products & technology

  • Mammography system (AIDIA Nex)Mammography system for breast cancer diagnosis
  • AIDIA VolveMammography system
  • 3D breast cancer diagnostic system (AIDIA LUXE)3D system for breast cancer diagnosis
  • Surgical X-ray C-arm system (EXTRON)Real-time fluoroscopy surgical X-ray equipment
  • Dental intraoral X-ray system (Xero)Dental intraoral X-ray imaging device
  • Human X-ray generator (DXG)Generator for human X-ray imaging systems
  • Human X-ray system (EXSYS DEXi)X-ray imaging system for human use
  • Industrial bendable/curved detector (EXTREAM FleX)Industrial non-destructive testing detector for pipelines, PCBs, semiconductors, etc.

Regulatory approvals

data.go.kr · openFDA

62 Korean MFDS device approvals · 2009–2026 / 31 US FDA 510(k) · 2008–2025

  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2026-06-10
    Product approval · Class 2제인 26-4507 호
  • MFDSX-ray system, diagnostic, mobile, digital2025-11-19
    Product approval · Class 2제인 25-5087 호
  • MFDSX-ray system, general-purpose, analogue2025-10-21
    Product approval · Class 2제인 25-4970 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2025-10-15
    Product approval · Class 2제인 25-4950 호
  • MFDSX-ray system, diagnostic, mobile, digital2025-08-04
    Product approval · Class 2제인 25-4709 호
  • FDAEXTRON 3; EXTRON 5; EXTRON 72025-06-10
    510(k) · TraditionalRadiologyK250010
  • FDAEXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG2025-03-20
    510(k) · SpecialRadiologyK242770
  • FDAEXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP2025-03-19
    510(k) · SpecialRadiologyK243443
  • MFDSMedical image, analog to digital transform, DR, CR2024-12-24
    Product approval · Class 2제인 24-1178 호
  • FDAXERO-alpha2024-11-01
    510(k) · TraditionalDentalK242591
  • FDAEXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);2024-10-23
    510(k) · SpecialRadiologyK242847
  • MFDSMedical image, analog to digital transform, DR, CR2024-10-14
    Product approval · Class 2제인 24-931 호
Show 68 more
  • FDAEConsole22024-09-23
    510(k) · TraditionalRadiologyK240243
  • FDAEXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)2024-07-26
    510(k) · TraditionalRadiologyK233530
  • MFDSMedical image, picture archiving and communication system, software, class 22024-05-14
    Product approval · Class 2제인 24-476 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2024-04-25
    Product approval · Class 2제인 24-434 호
  • MFDSMedical image, analog to digital transform, DR, CR2024-04-18
    Product approval · Class 2제인 24-401 호
  • MFDSMammographic x-ray system, stationary, digital2024-04-12
    Product approval · Class 2제인 24-382 호
  • MFDSMedical image, picture archiving and communication system, software, class 22024-03-25
    Product approval · Class 2제인 24-324 호
  • MFDSMedical image, analog to digital transform, DR, CR2024-03-12
    Product approval · Class 2제인 24-268 호
  • FDAEXPD 4343S2024-02-13
    510(k) · SpecialRadiologyK232082
  • FDAEXPD 4343D; EXPD 3643D2023-11-16
    510(k) · SpecialRadiologyK232753
  • MFDSX-ray system, diagnostic, general-purpose, digital2023-11-09
    Product approval · Class 2제인 23-5244 호
  • MFDSX-ray system, general-purpose, analogue2023-11-09
    Product approval · Class 2제인 23-5243 호
  • FDAEConsole12023-10-18
    510(k) · TraditionalRadiologyK231225
  • MFDSMedical image, analog to digital transform, DR, CR2023-10-13
    Product approval · Class 2제인 23-5162 호
  • MFDSMammographic x-ray system, stationary, digital2023-09-26
    Product approval · Class 2제인 23-5127 호
  • FDAEXTRON 5; EXTRON 72023-08-17
    510(k) · TraditionalRadiologyK230871
  • FDAEXPD 4357; EXPD 4357P2023-08-01
    510(k) · SpecialRadiologyK231959
  • MFDSMedical image, picture archiving and communication system, software, class 22023-06-29
    Product approval · Class 2제인 23-4850 호
  • MFDSMedical image, analog to digital transform, DR, CR2023-06-08
    Product approval · Class 2제인 23-4793 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2023-06-05
    Product approval · Class 2제인 23-4787 호
  • MFDSX-ray system, general-purpose, analogue2023-06-05
    Product approval · Class 2제인 23-4786 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2023-03-03
    Product approval · Class 2제인 23-199 호
  • FDARMF-20002023-01-26
    510(k) · TraditionalRadiologyK220073
  • MFDSMedical image, analog to digital transform, DR, CR2022-12-12
    Product approval · Class 2제인 22-4982 호
  • FDAEXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG2022-11-18
    510(k) · SpecialRadiologyK223124
  • MFDSMedical image, analog to digital transform, DR, CR2022-10-24
    Product approval · Class 2제인 22-4813 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2022-05-27
    Product approval · Class 2제인 22-4415 호
  • MFDSX-ray system, general-purpose, analogue2022-05-26
    Product approval · Class 2제인 22-4411 호
  • MFDSX-ray system, diagnostic, mobile, analogue2022-05-23
    Product approval · Class 2제인 22-4405 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2022-05-23
    Product approval · Class 2제인 22-4404 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2022-05-23
    Product approval · Class 2제인 22-4403 호
  • MFDSX-ray system, diagnostic, mobile, analogue2022-05-23
    Product approval · Class 2제인 22-4402 호
  • MFDSX-ray system, general-purpose, analogue2022-05-23
    Product approval · Class 2제인 22-4401 호
  • MFDSX-ray system, general-purpose, analogue2022-05-23
    Product approval · Class 2제인 22-4400 호
  • MFDSX-ray system, general-purpose, analogue2022-05-23
    Product approval · Class 2제인 22-4399 호
  • MFDSX-ray system, general-purpose, analogue2021-10-28
    Product approval · Class 2제인 21-4922 호
  • MFDSX-ray system, general-purpose, analogue2021-10-28
    Product approval · Class 2제인 21-4921 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2021-10-22
    Product approval · Class 2제인 21-4902 호
  • MFDSTable, x-ray system, diagnostic, electrically-powered2021-10-14
    Product approval · Class 1제신 21-1368 호
  • MFDSX-ray system, diagnostic, general-purpose, digital2021-05-03
    Product approval · Class 2제인 21-4375 호
  • MFDSX-ray system, general-purpose, analogueRevoked2021-04-29
    Product approval · Class 2제인 21-4362 호
  • MFDSMammographic x-ray system, stationary, digital2020-04-23
    Product approval · Class 2제인 20-4309 호
  • MFDSMedical image, analog to digital transform, DR, CR2019-12-23
    Product approval · Class 2제인 19-5041 호
  • MFDSMedical image, analog to digital transform, DR, CR2019-12-10
    Product approval · Class 2제인 19-4987 호
  • FDAEVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP2019-11-22
    510(k) · SpecialRadiologyK193017
  • FDAEXPD 4343P, EXPD 3643P2019-11-22
    510(k) · SpecialRadiologyK193031
  • MFDSX-ray system, general-purpose, analogueRevoked2019-10-04
    Product approval · Class 2제인 19-4823 호
  • FDAEVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG2019-10-03
    510(k) · SpecialRadiologyK192400
  • MFDSMedical image, analog to digital transform, DR, CR2019-09-10
    Product approval · Class 2제인 19-4772 호
  • MFDSX-ray system, general-purpose, analogue2019-09-06
    Product approval · Class 2제인 19-4767 호
  • MFDSMedical image, analog to digital transform, DR, CR2019-08-02
    Product approval · Class 2제인 19-4646 호
  • FDAEVS 2430W, EVS 2430GW2017-05-15
    510(k) · SpecialRadiologyK171137
  • MFDSMedical image, analog to digital transform, DR, CR2017-05-11
    Product approval · Class 2제인 17-4334 호
  • FDARSM 2430C2017-04-27
    510(k) · SpecialRadiologyK170930
  • FDARSM 1824C with RConsole12017-02-23
    510(k) · TraditionalRadiologyK162670
  • FDAEVS 4343, EVS 4343G2016-12-21
    510(k) · SpecialRadiologyK162555
  • FDAEVS 3643, EVS 3643G2016-12-02
    510(k) · SpecialRadiologyK162552
  • MFDSMedical image, analog to digital transform, DR, CR2016-11-21
    Product approval · Class 2제인 16-4860 호
  • FDAEconsole12015-12-14
    510(k) · TraditionalRadiologyK152172
  • FDAEVS 36432015-10-21
    510(k) · TraditionalRadiologyK151942
  • MFDSMedical image, analog to digital transform, DR, CR2015-09-02
    Product approval · Class 2제인 15-4099 호
  • MFDSMedical image, analog to digital transform, DR, CR2015-05-06
    Product approval · Class 2제인 15-676 호
  • FDAEVS 43432015-01-15
    510(k) · TraditionalRadiologyK142475
  • MFDSMedical image, analog to digital transform, DR, CR2014-04-22
    Product approval · Class 2제인 14-916 호
  • FDAFLAATZ 600 SERIES (FLAATZ 600/601)2014-02-21
    510(k) · SpecialRadiologyK132842
  • MFDSX-ray system, diagnostic, mobile, digitalRevoked2013-08-27
    Product approval · Class 2제인 13-1479 호
  • MFDSX-ray system, diagnostic, mobile, digitalRevoked2013-08-27
    Product approval · Class 2제인 13-1480 호
  • MFDSMedical image, analog to digital transform, DR, CRRevoked2013-04-29
    Product approval · Class 2제인 13-759 호

Showing the 80 most recent of 93 records.

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.

DRGEM CORPORATION10 shared

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

SGHEALTHCARE CO.,LTD.8 shared

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

Vieworks Co., Ltd.7 shared

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

RAYENCE CO.,LTD.5 shared

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

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.

GENORAY Co., LTD.2 shared

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

INFINITT Healthcare Co., Ltd.2 shared

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

JPI Healthcare Co., Ltd.2 shared

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

Bistos Co., Ltd.1 shared

Founded in 2001 and KOSDAQ-listed in 2022, Bistos manufactures fetal, neonatal, and patient monitoring medical devices.

DEEPNOID Inc.1 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
SELVAS Healthcare, Inc.1 shared

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

Sources and updates

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

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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