DRGEM, The Republic of Korea - Komachine Supplier Profile and Product List

- DRGEM, a specialized medical imaging equipment manufacturer, with expertise in X-ray generators, X-ray imaging systems, and DR upgrade solutions. A company aiming for global leadership in diagnostic X-ray markets through high-quality, low-dose system development.DRGEM, a specialized medical imaging equipment manufacturer, with expertise in X-ray generators, X-ray imaging systems, and DR upgrade solutions. A company aiming for global leadership in diagnostic X-ray markets through high-quality, low-dose system development.
- High-Frequency X-ray Generators: A diverse portfolio including GXR Series, MXR-35 for Mammography, Stand Alone GXR-U Series, and Capacitor Assisted GXR-C Series. Accumulation of unique know-how in high voltage insulation, high power conversion, and high voltage control technologies. Specific suitability of these generators for small hospitals, clinics, and developing countries with challenging power supplies.High-Frequency X-ray Generators: A diverse portfolio including GXR Series, MXR-35 for Mammography, Stand Alone GXR-U Series, and Capacitor Assisted GXR-C Series. Accumulation of unique know-how in high voltage insulation, high power conversion, and high voltage control technologies. Specific suitability of these generators for small hospitals, clinics, and developing countries with challenging power supplies.
- Digital Radiography Systems: An extensive lineup featuring fixed systems (GXR-S Series, GXR-SD Series, All-in-One DIAMOND) and mobile systems (TOPAZ, JADE, PROMO). TOPAZ, a state-of-the-art mobile system, designed for maximum patient and user comfort, with efficient workflow and superior image quality. PROMO, an FDA-approved mobile X-ray system, for versatile application in emergency rooms, disaster sites, and various medical environments. Development of Veterinary Digital Radiography Systems, VXR Series and VXR-E/EC models.Digital Radiography Systems: An extensive lineup featuring fixed systems (GXR-S Series, GXR-SD Series, All-in-One DIAMOND) and mobile systems (TOPAZ, JADE, PROMO). TOPAZ, a state-of-the-art mobile system, designed for maximum patient and user comfort, with efficient workflow and superior image quality. PROMO, an FDA-approved mobile X-ray system, for versatile application in emergency rooms, disaster sites, and various medical environments. Development of Veterinary Digital Radiography Systems, VXR Series and VXR-E/EC models.
- DR Upgrade Solutions: ACQUIDR, a digital imaging system adaptable to existing analog X-ray systems. Provision of user convenience through automatic exposure detection (AED) function and an intuitive graphical user interface.DR Upgrade Solutions: ACQUIDR, a digital imaging system adaptable to existing analog X-ray systems. Provision of user convenience through automatic exposure detection (AED) function and an intuitive graphical user interface.
- Imaging Software: RADMAX software, featuring AI-based diagnostic assistance (bone suppression, scatter reduction, positioning guides), auto-stitching, and support for various protocols including DICOM, HL7, RDSR. Implementation of efficient workflow through seamless integration with PACS, RIS, HIS, EMR, and PMS. Core technology for achieving high image quality at low doses.Imaging Software: RADMAX software, featuring AI-based diagnostic assistance (bone suppression, scatter reduction, positioning guides), auto-stitching, and support for various protocols including DICOM, HL7, RDSR. Implementation of efficient workflow through seamless integration with PACS, RIS, HIS, EMR, and PMS. Core technology for achieving high image quality at low doses.
- Other Product Categories: In-house development and production of core components such as X-ray tubes, collimators, and imaging software. Recent expansion of the product portfolio with ultrasound systems (DS20, DS30) and the radiography training solution RadTrainer.Other Product Categories: In-house development and production of core components such as X-ray tubes, collimators, and imaging software. Recent expansion of the product portfolio with ultrasound systems (DS20, DS30) and the radiography training solution RadTrainer.
- X-ray Technology Specialization and Extensive Experience: A technology-driven company with over 20 years of exclusive focus on X-ray imaging equipment since its establishment in 2003. Specialized expertise in the development and manufacturing of diagnostic X-ray systems.X-ray Technology Specialization and Extensive Experience: A technology-driven company with over 20 years of exclusive focus on X-ray imaging equipment since its establishment in 2003. Specialized expertise in the development and manufacturing of diagnostic X-ray systems.
- Comprehensive Product Portfolio: Offering a wide range of diagnostic X-ray systems for human and veterinary medicine, including stationary, mobile, and upgrade solutions. Provision of integrated solutions from high-frequency X-ray generators to DR systems and imaging software.Comprehensive Product Portfolio: Offering a wide range of diagnostic X-ray systems for human and veterinary medicine, including stationary, mobile, and upgrade solutions. Provision of integrated solutions from high-frequency X-ray generators to DR systems and imaging software.
- Advanced Technology and R&D Capabilities: Possession of core X-ray generator technologies such as high voltage insulation, high power conversion, and high voltage control. Continuous research and development capabilities, including AI-based diagnostic assistance, auto-positioning, and auto-stitching features. Realization of world-class 500kHz ultra-high frequency control technology.Advanced Technology and R&D Capabilities: Possession of core X-ray generator technologies such as high voltage insulation, high power conversion, and high voltage control. Continuous research and development capabilities, including AI-based diagnostic assistance, auto-positioning, and auto-stitching features. Realization of world-class 500kHz ultra-high frequency control technology.
- Global Certifications and Quality Reliability: Attainment of numerous international certifications including CE, FDA, CSA, USTC, ISO13485, EU MDR, Health Canada MDL, and ANVISA. Demonstration of compliance with the highest standards of safety, performance, and quality across all products.Global Certifications and Quality Reliability: Attainment of numerous international certifications including CE, FDA, CSA, USTC, ISO13485, EU MDR, Health Canada MDL, and ANVISA. Demonstration of compliance with the highest standards of safety, performance, and quality across all products.
- Strategic Partnerships and Distribution Network: Establishment of strategic partnerships with major corporations such as Fujifilm Corporation and Samsung Electronics. Leveraging Fujifilm's worldwide distribution network for stable sales channels. Operation of an extensive global network with over 150-200 distribution partners across 120-150 countries worldwide.Strategic Partnerships and Distribution Network: Establishment of strategic partnerships with major corporations such as Fujifilm Corporation and Samsung Electronics. Leveraging Fujifilm's worldwide distribution network for stable sales channels. Operation of an extensive global network with over 150-200 distribution partners across 120-150 countries worldwide.
- Cost-Effectiveness and Compatibility: Design for backward and forward compatibility, enabling cost-effective component upgrades without full system replacement. Ability to offer highly customizable systems at competitive prices to meet diverse customer requirements.Cost-Effectiveness and Compatibility: Design for backward and forward compatibility, enabling cost-effective component upgrades without full system replacement. Ability to offer highly customizable systems at competitive prices to meet diverse customer requirements.
- Patient Safety and Workflow Optimization: Prioritization of patient safety through low-dose, high-quality imaging technology, Automatic Exposure Control (AEC), and smart dose-monitoring tools. Provision of efficient workflow through auto-tracking, auto-positioning features, and intuitive interfaces.Patient Safety and Workflow Optimization: Prioritization of patient safety through low-dose, high-quality imaging technology, Automatic Exposure Control (AEC), and smart dose-monitoring tools. Provision of efficient workflow through auto-tracking, auto-positioning features, and intuitive interfaces.
- Patient diagnosis in medical institutions such as hospitals and clinicsPatient diagnosis in medical institutions such as hospitals and clinics
- Veterinary hospitals and animal treatment sectorsVeterinary hospitals and animal treatment sectors
- Specialized medical fields including radiology and chiropractic clinicsSpecialized medical fields including radiology and chiropractic clinics
- Various medical environments requiring mobile X-ray systems, such as emergency rooms, disaster sites, and military medical supportVarious medical environments requiring mobile X-ray systems, such as emergency rooms, disaster sites, and military medical support
- SADC member countries (supply through DRGEM Africa Corporation)SADC member countries (supply through DRGEM Africa Corporation)
- South Korea (domestic market), China (strengthened local production and distribution through subsidiary Weihai DRGEM Medical Equipment Co Ltd)South Korea (domestic market), China (strengthened local production and distribution through subsidiary Weihai DRGEM Medical Equipment Co Ltd)
- European market (distribution authorized by EU MDR certification), Turkey (a major export market)European market (distribution authorized by EU MDR certification), Turkey (a major export market)
- United States (a strong export market, FDA approval, establishment of DRGEM America Inc.), Canada (Class II MDL certification obtained)United States (a strong export market, FDA approval, establishment of DRGEM America Inc.), Canada (Class II MDL certification obtained)
- Australia (product sales and support through Medic Cloud)Australia (product sales and support through Medic Cloud)
- Brazil (ANVISA approval for TOPAZ, JADE)Brazil (ANVISA approval for TOPAZ, JADE)
- CE CertificationCE Certification
- US FDA 510(k) Approval (all products by October 2019, including GXR series, DIAMOND, PROMO mobile X-ray system)US FDA 510(k) Approval (all products by October 2019, including GXR series, DIAMOND, PROMO mobile X-ray system)
- CSA CertificationCSA Certification
- USTC CertificationUSTC Certification
- ISO13485 CertificationISO13485 Certification
- EU MDR (European Union Medical Device Regulation 2017/745) Certification (obtained June 12, 2025, for diagnostic X-ray systems, digital diagnostic X-ray systems, mobile X-ray systems, digital imaging systems, high voltage X-ray generators, rotating anode X-ray tube assemblies, X-ray collimators)EU MDR (European Union Medical Device Regulation 2017/745) Certification (obtained June 12, 2025, for diagnostic X-ray systems, digital diagnostic X-ray systems, mobile X-ray systems, digital imaging systems, high voltage X-ray generators, rotating anode X-ray tube assemblies, X-ray collimators)
- Health Canada Class II Medical Device Licenses (MDL) (for 5 product groups and 9 models including GXR-S/CS, GXR-ES/ECS, TOPAZ, JADE, AcquiDR)Health Canada Class II Medical Device Licenses (MDL) (for 5 product groups and 9 models including GXR-S/CS, GXR-ES/ECS, TOPAZ, JADE, AcquiDR)
- Brazil ANVISA Approval (TOPAZ, JADE)Brazil ANVISA Approval (TOPAZ, JADE)
- Venture Business CertificationVenture Business Certification
- GMP (Good Manufacturing Practice)GMP (Good Manufacturing Practice)
- Technical Competence: Core X-ray generator technologies such as high voltage insulation, high power conversion, and high voltage control. Realization of world-class 500kHz ultra-high frequency control technology. Innovative software technologies including AI-based diagnostic assistance, auto-stitching, auto-tracking, and auto-positioning.Technical Competence: Core X-ray generator technologies such as high voltage insulation, high power conversion, and high voltage control. Realization of world-class 500kHz ultra-high frequency control technology. Innovative software technologies including AI-based diagnostic assistance, auto-stitching, auto-tracking, and auto-positioning.