Change Healthcare Canada Company FDA Approvals

0 new drug approvals and 2 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
Change Healthcare Stratus Imaging PACS510(k)Nov 12, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 12, 2024
Change Healthcare Anatomical AI510(k)Jul 20, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 20, 2021