DRTECH Corporation - FDA 510(k) Cleared Devices

DRTECH Corporation, is a Radiology device manufacturer with a manufacturing facility in Seongnam-Si, Korea. The company specializes in comprehensive X-ray imaging solutions, including mobile C-arm systems, digital mammography, general radiography systems, and digital detectors for medical and industrial applications.

DRTECH has received 25 FDA 510(k) clearances from 25 total submissions since 2015. The company maintains an active regulatory presence, with its most recent clearance in 2025. All submissions have focused on Radiology devices, reflecting the company's core expertise in diagnostic imaging technology.

Notable cleared devices include the EXTRON surgical C-arm system, AIDIA digital mammography platform, and the EXPD detector series for general radiography. The company has also developed specialized solutions such as bendable and curved detectors, long-length imaging panels, and dual-energy X-ray systems. DRTECH operates a global network with offices across North America, Europe, China, and Japan.

Explore the complete list of FDA 510(k) cleared devices, product codes, and clearance dates in the database.