-Global medical imaging solutions company DRGEM is accelerating its push into North America after receiving U.S. Food and Drug Administration (FDA) clearance for its mobile X-ray system, “RAYMO.”
DRGEM announced on the 15th that RAYMO had received FDA clearance. The FDA is known for its demanding and rigorous review process, making the clearance official confirmation that RAYMO’s safety and effectiveness exceed global standards and meet the highest levels worldwide.
RAYMO is a next-generation mobile X-ray system built around a lightweight, compact design. It enhances mobility and ease of use with features tailored to clinical settings, including a collimator source-to-image distance (SID) vibration guide, barcode scanner, radio-frequency identification (RFID), and drive camera. The system also delivers stable, efficient imaging across a range of clinical environments.
“Receiving FDA clearance is a meaningful achievement that officially recognizes RAYMO’s technological capabilities and product competitiveness,” said DRGEM CEO Park Jeong-byeong. “Building on this milestone, we will expand our presence in North America and grow into a trusted partner in the global medical imaging equipment market.”
DRGEM primarily exports digital X-ray equipment and other digital medical imaging solutions. The company has recently expanded its portfolio to include digital imaging software and ultrasound systems. With this clearance, DRGEM plans to strengthen its presence in North America and continue developing imaging solutions tailored to diverse medical settings while expanding its global market reach.
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