Skip to content

Varian Mobius 3D 2.1

by Varian Medical Systems, Inc.

Varian Mobius 3D 2.1 is a Class II device made by Varian Medical Systems, Inc., cleared under FDA 510(k) K153014 on 29 Apr 2016 and listed in FDA GUDID since 30 Oct 2019 (UDI-DI 00899475002431), active as of 8 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

510(k) K153014

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00899475002431 UDI-DI Date30 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153014 Date29 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153014 decided 29 Apr 2016 Active
  • FDA GUDID UDI-DI 00899475002431 listed 30 Oct 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153014
  2. Listed FDA GUDID 00899475002431

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Varian Mobius 3D
Generic name
Radiation therapy software
Model / reference
2.1
Primary DI / UDI-DI
00899475002431
510(k) Number
FDA product code
IYE
GMDN term
Radiation therapy software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiation therapy software

Similar devices in this category

Other devices filed under Radiation therapy software.

Other devices from Varian Medical Systems, Inc.

See all devices from Varian Medical Systems, Inc. →

Properties

  • Lot / batch number
Other properties (14, all answered No)