Canon, Inc. - FDA 510(k) Cleared Devices

Canon, Inc. is a Japanese multinational corporation headquartered in ÅŒta, Tokyo, specializing in optical, imaging, and industrial products including lenses, cameras, scanners, and semiconductor manufacturing equipment.

Canon has received 43 FDA 510(k) clearances from 43 total submissions since 1994. The company's regulatory focus centers on Radiology devices, which represent 74% of submissions. The latest clearance was in 2024, demonstrating continued active engagement with FDA regulatory pathways.

Canon's cleared device portfolio includes digital radiography systems and ophthalmic imaging equipment. These products reflect the company's core expertise in advanced imaging technologies and optical systems for medical diagnostics.

Explore Canon's complete FDA 510(k) clearance history, including specific device names, product codes, and clearance dates in the regulatory database.

Regulatory submissions have been managed by Ken Block Consulting, Ken Block Consulting, LLC and Ora, Inc..