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TrueBeam 4.1

by Varian Medical Systems, Inc.

Part of a family of 8 devices: see the family page

Ref TrueBeam 4.1

TrueBeam 4.1 is a device classified as Class IIb in the EU and Class II in the US made by Varian Medical Systems, Inc., cleared under FDA 510(k) K252948 on 7 Oct 2025 (1 earlier submission), registered in EUDAMED on 8 Oct 2024 (Basic UDI-DI 089947500200122PJ) and listed in FDA GUDID since 26 Jun 2024 (UDI-DI 00858086006832), active as of 8 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252948

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK252948 Date7 Oct 2025DecidedStatusActive
European UnionCE/MDR EUDAMED Number089947500200122PJ Basic UDI-DI 00858086006832UDI-DIDate8 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00858086006832 UDI-DI Date26 Jun 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • FDA 510(k) K252948 decided 7 Oct 2025 Active· +1 more in the status table
  • EUDAMED Basic UDI-DI 089947500200122PJ registered 8 Oct 2024 Active
  • FDA GUDID UDI-DI 00858086006832 listed 26 Jun 2024 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K232870
  2. Listed FDA GUDID 00858086006832
  3. Registered EUDAMED 089947500200122PJ
  4. Cleared FDA 510(k) K252948

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
TrueBeam
Generic name
Linear accelerator system
Device name
TrueBeam-TrueBeam STx-Edge and VitalBeam
Model / reference
TrueBeam 4.1 EUDAMED
4.1 GUDID
Primary DI / UDI-DI
00858086006832
Basic UDI-DI
089947500200122PJ
Direct marketing DI
00858086006832
510(k) Number
FDA product code
IYE
EMDN code
Z11010103 Multi and high energy linear accelerators
GMDN term
Linear accelerator system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TrueBeam 4.1
GUDID
4.1
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Linear accelerator system

Similar devices in this category

Other devices filed under LINEAR ACCELERATORS.

Other devices from Varian Medical Systems, Inc.

See all devices from Varian Medical Systems, Inc. →

Properties

  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)