Canon Medical Informatics, Inc. FDA Approvals

0 new drug approvals and 5 device clearances on file. Matched by name to CAJPY.

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
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning510(k)May 22, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 22, 2026
CT VScore+510(k)Nov 28, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 28, 2025
Vitrea CT VScore510(k)Apr 10, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 10, 2025
Open Rib510(k)Jul 13, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 13, 2023
Vitrea CT Cardiac Analysis510(k)Oct 14, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 14, 2022