Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha FDA Approvals

0 new drug approvals and 2 device clearances on file. Matched by name to HTHIY.

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
PROBEAT-FR510(k)Jan 12, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 12, 2024
Small Field Applicator510(k)Dec 15, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 15, 2022