Skip to content

SunSCAN 3D 1235

by Sun Nuclear Corporation

Ref 1325Model 1234, 1235

SunSCAN 3D 1235 (1235900Z) 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 22 Oct 2025 (Basic UDI-DI 506060888WTSunSCAN3D3G) with CE/MDR certificate 28620200479 valid until 6 Jan 2028, cleared under FDA 510(k) K101992 on 1 Oct 2010 and listed in FDA GUDID since 8 Jun 2023 (UDI-DI 05060608881130), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

6 Jan 2028

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

510(k) K101992

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506060888WTSunSCAN3D3G Basic UDI-DI 05060608881130UDI-DIDate22 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060608881130 UDI-DI Date8 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK101992 Date1 Oct 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506060888WTSunSCAN3D3G registered 22 Oct 2025 Active· +1 more in the status table
  • FDA 510(k) K101992 decided 1 Oct 2010 Active
  • FDA GUDID UDI-DI 05060608881130 listed 8 Jun 2023 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

5 dated events

  1. Cleared FDA 510(k) K101992
  2. Listed FDA GUDID 05060608881130
  3. Certificate issued EUDAMED 28620200479
  4. Registered EUDAMED 506060888WTSunSCAN3D3G
  5. Certificate expires EUDAMED 28620200479

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  • Withdrawn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
SunSCAN 3D System EUDAMED
SunSCAN 3D GUDID
Generic name
Accelerator system quality assurance device
Model / Ref / Catalog
1234, 1235, 1325, 1235900Z
Primary DI / UDI-DI
05060608881130
Basic UDI-DI
506060888WTSunSCAN3D3G
510(k) Number
FDA product code
IYE
EMDN code
Z11010180 Linear accelerators - hardware accessories
GMDN term
Accelerator system quality assurance device
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
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
1234, 1235
1325
GUDID
1235
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: Accelerator system quality assurance device

Cleared under the same submission (K101992)

and 6 more cleared under K101992

Similar devices in this category

Other devices filed under LINEAR ACCELERATORS - HARDWARE ACCESSORIES.

Other devices from Sun Nuclear Corporation

See all devices from Sun Nuclear Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)