Shimadzu Corp. - FDA 510(k) Cleared Devices

Shimadzu Corp., is a Japanese manufacturer of precision instruments and medical equipment, established in 1875 and based in Kyoto, Japan. The American division, Shimadzu Scientific Instruments, was founded in 1975 and operates from McHenry, US.

Shimadzu has received 49 FDA 510(k) clearances from 49 total submissions, with no denied submissions on record. The company's regulatory focus centers on Radiology devices, which represent 98% of its FDA 510(k) portfolio. Clearances span from 1979 to 2015, establishing a long historical record in medical device regulation.

Recent cleared devices include mobile and stationary X-ray systems, collimators, and fluoroscopy equipment. These products reflect the company's specialization in diagnostic imaging and radiological instrumentation.

This company profile is maintained as a historical regulatory record. Explore the complete list of device names, product codes, and clearance dates in the database.