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RT Elements, 4.6

by Brainlab SE

Ref 04056481147112

RT Elements, 4.6 (04056481147112) is a device classified as Class IIb in the EU and Class II in the US made by Brainlab SE, cleared under FDA 510(k) K261655 on 5 Oct 2026, registered in EUDAMED on 1 Jul 2025 (Basic UDI-DI 4056481RTElementsW8) and listed in FDA GUDID since 22 Oct 2026 (UDI-DI 04056481147112), active as of 2 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 2 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K261655

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04056481147112 UDI-DI Date22 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK261655 Date5 Oct 2026DecidedStatusActive
European UnionCE/MDR EUDAMED Number4056481RTElementsW8 Basic UDI-DI 04056481147112UDI-DIDate1 Jul 2025RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K261655 decided 5 Oct 2026 Active
  • EUDAMED Basic UDI-DI 4056481RTElementsW8 registered 1 Jul 2025 Active
  • FDA GUDID UDI-DI 04056481147112 listed 22 Oct 2026 Listed

Timeline

3 dated events

  1. Registered EUDAMED 4056481RTElementsW8
  2. Cleared FDA 510(k) K261655
  3. Listed FDA GUDID 04056481147112

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  • Withdrawn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, 4.6 EUDAMED
RT Elements GUDID
Generic name
Radiation therapy planning software
Model / reference
04056481147112 EUDAMED
4.7 GUDID
Primary DI / UDI-DI
04056481147112
Basic UDI-DI
4056481RTElementsW8
510(k) Number
FDA product code
OLO
EMDN code
Z11010492 Radiotherapy treatment planning instruments - medical device software
GMDN term
Radiation therapy planning software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.4560
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
04056481147112
GUDID
4.7
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)