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Plan AI 1057

by Sun Nuclear Corporation

Ref 1057

Plan AI 1057 is a device classified as Class IIb in the EU and Class II in the US made by Sun Nuclear Corporation, registered in EUDAMED on 14 May 2026 (Basic UDI-DI 506060888PlanAIXR), cleared under FDA 510(k) K242748 on 11 Apr 2025 and listed in FDA GUDID since 7 Nov 2025 (UDI-DI 05060608881574), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242748

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506060888PlanAIXR Basic UDI-DI 05060608881574UDI-DIDate14 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060608881574 UDI-DI Date7 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK242748 Date11 Apr 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506060888PlanAIXR registered 14 May 2026 Active
  • FDA 510(k) K242748 decided 11 Apr 2025 Active
  • FDA GUDID UDI-DI 05060608881574 listed 7 Nov 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K242748
  2. Listed FDA GUDID 05060608881574
  3. Registered EUDAMED 506060888PlanAIXR

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  • Withdrawn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
Plan AI
Generic name
Radiation therapy software
Model / reference
1057
Primary DI / UDI-DI
05060608881574
Basic UDI-DI
506060888PlanAIXR
510(k) Number
FDA product code
MUJ
EMDN code
Z11010192 Linear accelerators - 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 · 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.

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Properties

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