FDA Approves Rayence Digital Radiography Unit

Digital radiography (DR) technology developer Rayence Inc.’s RU-3000 universal DR system has received 510(k) clearance from the U.S. Food and Drug Administration.

The system features a small footprint and compact design, as well as dual telescoping arm movement that enables installation in settings with ceiling heights of only 8 ft.

RU-3000 has fully motorized movements for source-to-image distance, arm rotation, height, and detector angle, which can be automatically programmed to user-specific positions by either the touchscreen or a handheld remote control. The system comes with a 17 by 17-inch cesium detector coupled with Rayence’s XmaruView workstation. RU-3000 is the first U-arm system marketed by Rayence in the United States, the company said. Complemented by a durable bucky design with an easily removable grid, patient safety anti-collision sensors, and an available mobile table, the RU-3000 is full featured and well-suited for all imaging environments, especially orthopedics, imaging centers, and urgent care.

“The RU-3000 represents an expansion of our product offering into X-ray generating equipment,” said Leo Park, president of Rayence Inc. “It is a progressive business step and speaks to the direction we’re taking with our company.”  

Headquartered in Fort Lee, N.J., Rayence Inc. is a subsidiary of Rayence Co., Ltd., a designer, developer, manufacturer and supplier of flat panel detectors (FPD) for digital radiography imaging systems. The company offers a wide array of a-Si TFT and CMOS X-ray detectors in a various sizes that are specifically designed to allow a customized solution for diagnostic medical, dental, veterinary, and industrial applications.