Shimadzu Corporation - FDA 510(k) Cleared Devices

Shimadzu Corporation, is a diversified manufacturer of analytical, measuring, and medical imaging instruments with a manufacturing facility in Kyoto, Japan. The company has operated for over 150 years, pioneering diagnostic imaging technologies and contributing to early disease detection and treatment worldwide.

Shimadzu has received 9 FDA 510(k) clearances from 9 total submissions, with all submissions focused on Radiology devices. The company's regulatory track record spans from 2014 to 2026, demonstrating sustained innovation in diagnostic imaging systems. Recent cleared devices include mobile C-arm systems, radiography platforms, and fluoroscopy equipment designed for surgical and diagnostic applications.

The company's Radiology portfolio emphasizes high-definition imaging, positioning flexibility, and operational efficiency. Products address diverse clinical specialties including orthopedics, emergency medicine, and oncology. Shimadzu's medical systems division continues to expand its lineup with advanced imaging technologies and automated positioning features.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database to review Shimadzu's regulatory submissions and cleared devices.

510(k) submissions have been managed by Kamm & Associates as regulatory consultant.