Shanghai United Imaging Healthcare Co., Ltd. - FDA 510(k) Cleared Dev...

Shanghai United Imaging Healthcare Co., Ltd. is a medical imaging company based in Shanghai, China. The company develops and manufactures advanced diagnostic imaging systems and related technologies.

The company has received 82 FDA 510(k) clearances from 82 total submissions, with all submissions focused on Radiology devices. FDA 510(k) clearances span from 2018 to 2026, demonstrating sustained regulatory activity and recent market approvals.

Recent cleared devices include advanced imaging systems such as magnetic resonance imaging (MRI) platforms, computed tomography (CT) scanners, digital radiography systems, and angiography solutions. The company also develops molecular imaging and radiotherapy systems alongside innovative medical imaging software solutions.

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