Viz. Ai, Inc. FDA Approvals

0 new drug approvals and 9 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
Viz Subdural+, Viz SUBDURAL PLUS510(k)Jun 10, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 10, 2025
Viz HDS, Viz Volume Plus, Viz ICH+510(k)Feb 5, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 5, 2024
Viz HCM510(k)Aug 3, 2023Cardiovascular	Cardiovascular	510(k)Unknown (Direct)	Aug 3, 2023
Viz AAA510(k)Mar 17, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 17, 2023
Viz LVO ContaCT510(k)Oct 21, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 21, 2022
Viz RV/LV510(k)Aug 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 29, 2022
Viz SDH510(k)Jul 25, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 25, 2022
Viz ANEURYSM, Viz ANX510(k)Feb 18, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 18, 2022
Viz ICH510(k)Mar 23, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 23, 2021