DRGEM announced that its PROMO Mobile X-ray System has received Traditional 510(k) Clearance from the U.S. Food and Drug Administration (FDA). This milestone confirms that PROMO meets all regulatory requirements for entry into the U.S. market, strengthening DRGEM’s position as a global leader in diagnostic imaging.
A Mobile X-ray Designed for Efficiency and Flexibility
PROMO was developed with clinical efficiency and hospital needs in mind. The system’s lightweight design ensures smooth maneuverability in confined spaces such as intensive care units, operating rooms, and emergency departments. At the same time, its wide imaging coverage supports versatile use, from routine chest radiography to specialized bedside examinations.
Key benefits of PROMO include:
- Compact & Mobile – Lightweight structure with push-down-and-go driving ensures smooth maneuverability even in tight hospital spaces.
- Positioning Flexibility – 180° rotating column, flexible tube head, and high focal spot height provide accurate imaging across diverse clinical needs.
- High-Quality Imaging with Efficiency – 40 kW capacitor generator and RADMAX software deliver sharp, reliable images while supporting a timely and streamlined workflow.
Commenting on the clearance, Mr. J.B. Park, President of DRGEM Corporation, stated:
“Achieving FDA 510(k) clearance for PROMO marks an important step forward in our mission to deliver world-class imaging solutions. PROMO was developed to meet the needs of clinicians who require timely, flexible, and reliable imaging at the point of care. By combining mobility, efficiency, and affordability, PROMO is ready to improve bedside imaging in the U.S. and beyond. This clearance shows our dedication to quality, innovation, and expanding access to advanced medical imaging worldwide.”
Strengthening DRGEM’s Global Strategy
The FDA clearance is not only a regulatory milestone but also a strategic advancement for DRGEM’s long-term vision. By meeting strict U.S. regulatory standards, PROMO demonstrates DRGEM’s ability to compete in the most advanced medical imaging markets. Its balance of high performance and cost-effectiveness positions it as an ideal solution for hospitals and clinics looking to enhance diagnostic efficiency without compromising quality.
As DRGEM continues to expand globally, PROMO reinforces its portfolio of advanced diagnostic systems now trusted in more than 120 countries. This milestone reaffirms DRGEM’s commitment to delivering complete imaging solutions that empower medical imaging professionals and improve patient outcomes across the globe.
👉 Learn more about PROMO: http://www.drgemhealthcare.com/products/promo
