Shimadzu Corporation Medical Systems Division 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
SET-5002510(k)May 24, 2024Radiology	Radiology	510(k)Substantially Equivalent (Abbreviated)	May 24, 2024
Trinias510(k)Jul 28, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 28, 2022