Canon Medical Systems Corporation - FDA 510(k) Cleared Devices

Canon Medical Systems Corporation is a Japanese medical equipment manufacturer based in ÅŒtawara, Tochigi. Now part of Canon Inc. following its 2016 acquisition, the company continues to operate as a leading provider of diagnostic imaging systems.

Canon Medical Systems has received 95 FDA 510(k) clearances from 95 total submissions since 2018. The company specializes exclusively in Radiology devices, with its latest clearance in 2026, demonstrating continued regulatory activity and product innovation.

The company's product portfolio centers on advanced imaging technologies including CT scanners, MRI systems, and diagnostic ultrasound platforms. Canon Medical Systems traces its heritage to 1914 as an early pioneer in X-ray tube development in Japan, establishing foundational expertise in medical imaging that remains central to its operations today.

Explore the complete regulatory record, including specific device names, product codes, and individual clearance dates in the database below.