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RAYSCAN α-Expert 3D, RAYSCAN α-3D

by Ray Co., Ltd

Ref RBS-A01Model RAYSCAN α-3D

RAYSCAN α-Expert 3D, RAYSCAN α-3D is a device classified as Class IIb in the EU and Class II in the US made by Ray Co., Ltd, registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI B-08800003027095), cleared under FDA 510(k) K232287 on 31 Aug 2023 (1 earlier submission) and listed in FDA GUDID since 25 Aug 2025 (UDI-DI 08800003027095), active as of 23 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232287

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800003027095 Basic UDI-DI 08800003027095UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800003027095 UDI-DI Date25 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK232287 Date31 Aug 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800003027095 registered 15 Oct 2026 Active
  • FDA 510(k) K232287 decided 31 Aug 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800003027095 listed 25 Aug 2025 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K190812
  2. Cleared FDA 510(k) K232287
  3. Listed FDA GUDID 08800003027095
  4. Registered EUDAMED B-08800003027095

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Device name
Dental X-ray System
Model / reference
RAYSCAN α-3D, RBS-A01
Primary DI / UDI-DI
08800003027095
Basic UDI-DI
B-08800003027095
510(k) Number
FDA product code
OAS
EMDN code
Z1103030102 Equipment for extraoral dental radiology, digital
GMDN term
Stationary panoramic/tomographic dental x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1750
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
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.

Related devices

Category: Stationary panoramic/tomographic dental x-ray system, digital

Cleared under the same submission (K190812)

and 2 more cleared under K190812

Cleared under the same submission (K232287)

and 3 more cleared under K232287

Similar devices in this category

Other devices filed under EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL.

Other devices from Ray Co., Ltd

See all devices from Ray Co., Ltd →

Properties

  • Serial number
  • Manufacturing date
Other properties (21, all answered No)