Carestream Health - FDA 510(k) Cleared Devices

Carestream Health, is a worldwide provider of X-ray imaging systems and precision coating services. The company is headquartered in Rochester, US.

Carestream has received 5 FDA 510(k) clearances from 5 total submissions, with all submissions focused on Radiology devices. The company's regulatory track record spans from 2017 to 2026, with its most recent clearance in 2026 demonstrating continued active development and market engagement.

The company specializes in digital radiography systems and detectors for medical imaging applications. Product lines include mobile X-ray systems, fixed radiography platforms, and advanced detector technologies designed for diagnostic imaging workflows.

Explore the complete list of cleared device names, product codes, and clearance dates in the database.