Fujifilm Medical Systems U.S.A, Inc. - FDA 510(k) Cleared Devices

Fujifilm Medical Systems U.S.A, Inc. is a healthcare imaging and diagnostics company with a manufacturing facility in Stamford, Connecticut. The company specializes in radiology devices, diagnostic imaging systems, and enterprise imaging solutions built on over 90 years of medical imaging expertise.

The company has received 39 FDA 510(k) clearances from 39 total submissions between 2005 and 2018. All submissions resulted in clearance. Radiology devices represent the dominant category, including digital radiography systems, flat panel detectors, image processing software, and picture archiving and communication systems (PACS).

Notable cleared devices include the ASPIRE Cristalle digital mammography system, FDR D-EVO flat panel detector systems, FDX Console image processing software, Synapse PACS enterprise imaging platform, and Synapse Cardiovascular analysis tools. The company's product portfolio encompasses digital radiography, surgical imaging, ultrasound, and in vitro diagnostics.

The company has been inactive in FDA 510(k) submissions for more than five years and should be treated as a historical regulatory record. Explore the complete list of cleared device names, product codes, and clearance dates in the database.