Koh Young receives MFDS approval for mobile X-ray system

Koh Young Technology said it received medical device certification from the Ministry of Food and Drug Safety (MFDS) for its mobile X-ray system, Geniant ez-X.

The Geniant ez-X is a mobile digital X-ray system designed to enhance convenience for medical professionals. Its compact design allows for efficient use in operating rooms, making it especially suitable for intraoperative imaging.

Koh Young plans to integrate the device with its neurosurgical robot, Geniant Cranial, in the future. The company expects that the combination will enable real-time X-ray imaging during brain surgeries, allowing surgeons to assess patient conditions and make timely decisions during procedures immediately.

X-ray imaging is one of the most frequently performed diagnostic tests in hospitals, as it uses radiation to quickly visualize internal structures, offering fast results with minimal procedure time.

“We expect strong synergy between the Geniant ez-X and our neurosurgical robot,” a Koh Young official said. “We plan to apply for U.S. FDA approval for the Geniant ez-X in the second half of this year and will continue to strengthen our competitiveness in the medical device market.”