Eizo Corporation - FDA 510(k) Cleared Devices

Eizo Corporation, is a global visual display manufacturer specializing in medical imaging solutions. The company operates with a manufacturing facility in Hakusan, Ishikawa, Japan, and serves healthcare, industrial, and professional markets worldwide.

Eizo has established a strong regulatory track record with the FDA. The company has received 29 FDA 510(k) clearances from 29 total submissions since its first clearance in 2013. Radiology devices represent the dominant focus, accounting for 93% of all submissions. The company remains actively engaged in regulatory submissions, with the latest clearance in 2025.

Eizo's cleared Radiology portfolio includes the RadiForce series of medical monitors, which span diagnostic imaging, mammography, and quality control applications. These devices support radiologists and clinicians in diagnostic and interventional procedures across multiple imaging modalities.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database to review Eizo's full regulatory history and cleared device specifications.