Varian Medical Systems FDA Approvals

0 new drug approvals and 10 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
AI Contouring (VA10A)510(k)Jul 10, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 10, 2026
MAASTRO Rectal Applicator Set510(k)May 20, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 20, 2026
Guided Aarhus Applicator Set510(k)Nov 19, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 19, 2025
Mobius3D (4.1)510(k)May 16, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 16, 2025
Intracavitary/Interstitial System510(k)Apr 25, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 25, 2025
Eclipse Treatment Planning System (18.1)510(k)Dec 11, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 11, 2024
Intraluminal Applicator Set510(k)Nov 26, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 26, 2024
Catheter Surface Flap Applicator Set (GM11011830)510(k)Oct 29, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 29, 2024
Vitesse (5.0)510(k)Oct 23, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 23, 2024
VariSeed (v10)510(k)Sep 8, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Sep 8, 2023