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Leksell GammaPlan 1567714

by Elekta Solutions AB

Ref 1567714Model Leksell GammaPlan 11

Leksell GammaPlan 1567714 is a device classified as Class IIb in the EU and Class II in the US made by Elekta Solutions AB, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 073402015BUDI000000022PF), cleared under FDA 510(k) K232854 on 8 Feb 2024 and listed in FDA GUDID since 14 Feb 2024 (UDI-DI 07340201502136), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232854

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number073402015BUDI000000022PF Basic UDI-DI 07340201502136UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07340201502136 UDI-DI Date14 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232854 Date8 Feb 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 073402015BUDI000000022PF registered 1 Oct 2026 Active
  • FDA 510(k) K232854 decided 8 Feb 2024 Active
  • FDA GUDID UDI-DI 07340201502136 listed 14 Feb 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K232854
  2. Listed FDA GUDID 07340201502136
  3. Registered EUDAMED 073402015BUDI000000022PF

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  • Withdrawn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
Leksell GammaPlan 11.4 EUDAMED
Leksell GammaPlan GUDID
Generic name
Stereotactic system application software
Model / reference
1567714, Leksell GammaPlan 11
Primary DI / UDI-DI
07340201502136
Basic UDI-DI
073402015BUDI000000022PF
510(k) Number
FDA product code
IWB, MUJ
EMDN code
Z11010782 Radiosurgery instruments - software accessories
GMDN term
Stereotactic system application software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5750, 892.5050
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Stereotactic system application software

Similar devices in this category

Other devices filed under RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS.

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Properties

  • Prescription use
  • Manufacturing date
Other properties (23, all answered No)