FUJIFILM Sonosite, Inc. - FDA 510(k) Cleared Devices

FUJIFILM Sonosite, Inc. is a portable ultrasound manufacturer based in Bothell, US. The company specializes in point-of-care ultrasound systems for clinical imaging.

FUJIFILM Sonosite has received 25 FDA 510(k) clearances from 25 total submissions since 2013. The company's portfolio focuses exclusively on Radiology devices. The latest clearance was in 2026, demonstrating continued regulatory activity and product innovation.

The company's cleared devices include portable ultrasound systems designed for diverse clinical settings. Products span multiple system lines, each configured for specific clinical workflows and procedural needs. FUJIFILM Sonosite maintains an active presence in the portable imaging market with regular product updates and clearances.

Explore the complete list of FDA 510(k) cleared devices, product codes, and clearance dates in the database.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.