Xact Robotics, 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
XACT Robotic System, ACE Model510(k)Sep 23, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 23, 2022
XACT ACE Robotic System510(k)May 13, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	May 13, 2022