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RT Elements, 4.0

by Brainlab SE

Ref 04056481144494

RT Elements, 4.0 (04056481144494) is a device classified as Class IIb in the EU and Class II in the US made by Brainlab SE, registered in EUDAMED on 1 Jul 2025 (Basic UDI-DI 4056481RTElementsW8), cleared under FDA 510(k) K223279 on 14 Mar 2023 and listed in FDA GUDID since 21 Jun 2023 (UDI-DI 04056481144494), active as of 22 Oct 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223279

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4056481RTElementsW8 Basic UDI-DI 04056481144494UDI-DIDate1 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04056481144494 UDI-DI Date21 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223279 Date14 Mar 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4056481RTElementsW8 registered 1 Jul 2025 Active
  • FDA 510(k) K223279 decided 14 Mar 2023 Active
  • FDA GUDID UDI-DI 04056481144494 listed 21 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223279
  2. Listed FDA GUDID 04056481144494
  3. Registered EUDAMED 4056481RTElementsW8

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  • Withdrawn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
RT Elements, 4.0 EUDAMED
RT Elements GUDID
Generic name
Radiation therapy software
Model / reference
04056481144494 EUDAMED
4.0 GUDID
Primary DI / UDI-DI
04056481144494
Basic UDI-DI
4056481RTElementsW8
Direct marketing DI
04056481144494
510(k) Number
FDA product code
MUJ
EMDN code
Z11010492 Radiotherapy treatment planning instruments - medical device software
GMDN term
Radiation therapy software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04056481144494
GUDID
4.0
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.

Manufacturer details

EUDAMED SRN
DE-MF-000006183

Similar devices in this category

Other devices filed under RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)