Carestream Health FDA Approvals

0 new drug approvals and 3 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
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System510(k)Mar 11, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 11, 2026
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector510(k)Jan 20, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 20, 2026
DRX-Rise Mobile X-ray System510(k)Mar 23, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 23, 2022