Carestream Health, Inc. - FDA 510(k) Cleared Devices

Carestream Health, Inc. is a worldwide provider of medical imaging systems and X-ray imaging solutions. The company operates with a manufacturing facility in Rochester, US and maintains a global service and support network across multiple markets.

Carestream has received 48 FDA 510(k) clearances from 48 total submissions since 2008. The company specializes in Radiology devices, which represent 94% of its regulatory submissions. The latest clearance was granted in 2025, demonstrating continued active development and market engagement.

Recent cleared devices include digital radiography systems, mobile X-ray platforms, and advanced imaging solutions featuring noise cancellation technology. The company's product portfolio spans diagnostic imaging, non-destructive testing, and precision contract manufacturing services across industrial and medical applications.

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