Carestream Health, Inc. FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Image Suite510(k)Sep 4, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 4, 2025
DRX-Revolution Mobile X-ray System510(k)Dec 10, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 10, 2024
DRX-Evolution Plus System510(k)Mar 12, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 12, 2024
DRX - Compass510(k)Jan 20, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jan 20, 2023
Eclipse II with Smart Noise Cancellation510(k)Jan 14, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 14, 2022
Eclipse II with Smart Noise Cancellation510(k)Apr 2, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 2, 2021