Fujifilm Healthcare Corporation FDA Approvals

0 new drug approvals and 6 device clearances on file. Matched by name to FUJIY.

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
ECHELON Synergy MRI System510(k)Aug 13, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 13, 2024
OASIS MRI System510(k)Apr 12, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 12, 2024
ECHELON Synergy MRI system510(k)Jul 13, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 13, 2023
ECHELON Oval V6.2 MRI System510(k)Jan 26, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 26, 2023
SCENARIA View510(k)May 23, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 23, 2022
ARIETTA 50510(k)Apr 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Abbreviated)	Apr 29, 2022