- Full-scale entry into the North American market… Meeting U.S. sales authorization requirements
- Proving competitiveness of the next-generation mobile X-ray system based on user-customized features
DRGEM (CEO J.B. Park), a global medical imaging solutions company, is accelerating its expansion into the North American market after obtaining U.S. Food and Drug Administration (FDA) clearance for its mobile X-ray system, “RAYMO.”
DRGEM announced on the 15th that its mobile X-ray system, ‘RAYMO,’ has received FDA clearance. The U.S. FDA certification is known for its rigorous and strict review process; therefore, this clearance serves as an official indicator that RAYMO’s safety and effectiveness exceed global standards and are at a world-class level.
RAYMO is a next-generation mobile X-ray system based on a lightweight and compact design. It enhances mobility and convenience by applying medical field-oriented, user-customized features such as a Collimator SID (Source-to-Image Distance) vibration guide, barcode scanner, Radio Frequency Identification (RFID), and a driving camera. Another key feature is its ability to provide stable and efficient imaging in various clinical environments.
Strategic Milestone for North American Market Leadership
“This FDA clearance is a meaningful achievement that officially recognizes RAYMO’s technological prowess and product competitiveness,” said J.B. Park, CEO of DRGEM. “Based on this milestone, we will expand our presence in the North American market and grow into a trusted partner in the global medical imaging equipment market.”
Diversifying the Digital Healthcare Portfolio
DRGEM provides digital medical imaging solutions, including digital X-ray devices, with a primary focus on overseas exports. Recently, the company has been expanding its business portfolio to include digital imaging software and ultrasound systems. With this certification as a catalyst, the company plans to increase its presence in North America and continue to strengthen its global market strategy and development of imaging medical solutions optimized for various medical environments.
