Xstrahl, Ltd. 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
XBeam (v2)510(k)Dec 4, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 4, 2024
X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)510(k)Jul 13, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 13, 2023