Skip to content

TrueBeam 3.0

by Varian Medical Systems, Inc.

TrueBeam 3.0 is a Class II device made by Varian Medical Systems, Inc., cleared under FDA 510(k) K223839 on 22 May 2023 (1 earlier submission) and listed in FDA GUDID since 10 Jun 2022 (UDI-DI 00899475002356), 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

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223839 Date22 May 2023DecidedStatusActive
United StatesGUDID listing Number00899475002356 UDI-DI Date10 Jun 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223839 decided 22 May 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00899475002356 listed 10 Jun 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213977
  2. Listed FDA GUDID 00899475002356
  3. Cleared FDA 510(k) K223839

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TrueBeam
Generic name
Linear accelerator system
Model / reference
3.0
Primary DI / UDI-DI
00899475002356
510(k) Number
FDA product code
IYE
GMDN term
Linear accelerator system
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Linear accelerator system

Cleared under the same submission (K213977)

Cleared under the same submission (K223839)

Other devices from Varian Medical Systems, Inc.

See all devices from Varian Medical Systems, Inc. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)