Genoray Co., Ltd. - FDA 510(k) Cleared Devices

Genoray Co., Ltd. is a medical device manufacturer specializing in Radiology devices, with a manufacturing facility in Flintville, US.

The company has received 24 FDA 510(k) clearances from 24 total submissions since its first clearance in 2007. Radiology devices represent the company's dominant focus across all regulatory submissions. The latest FDA 510(k) clearance was granted in 2026, confirming active regulatory engagement.

Genoray's cleared portfolio includes digital radiography systems, advanced imaging platforms, and specialized Radiology equipment designed for clinical and diagnostic applications. Recent cleared devices demonstrate the company's continued innovation in imaging technology and system integration.

Explore the complete list of device names, product codes, and clearance dates to review Genoray's full regulatory history and cleared product portfolio.

510(k) submissions have been managed by Genoray America, Inc. as regulatory consultant.