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RAYSCAN STUDIO, Vision 20, RAYPreMiere, RAYSCAN S, Vision 18, RCT800

by Ray Co., Ltd

Ref RBS-RS01Model RCT800

RAYSCAN STUDIO, Vision 20, RAYPreMiere, RAYSCAN S, Vision 18, RCT800 is a medical device (EU MDD Class IIb; FDA Class II; FDA product code OAS, X-Ray, Tomography, Computed, Dental; EMDN category equipment for extraoral dental radiology) made by Ray Co., Ltd, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-08800003027057), cleared under FDA 510(k) K260462 on 9 Apr 2026 (3 earlier submissions) and listed in FDA GUDID since 25 Aug 2025 (UDI-DI 08800003027057), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K260462

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800003027057 Basic UDI-DI 08800003027057UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK260462 Date9 Apr 2026DecidedStatusActive
United StatesGUDID listing GUDID Number08800003027057 UDI-DI Date25 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800003027057 registered 20 Oct 2026 Active
  • FDA 510(k) K260462 decided 9 Apr 2026 Active· +3 more in the status table
  • FDA GUDID UDI-DI 08800003027057 listed 25 Aug 2025 Listed

Timeline

6 dated events

  1. Cleared FDA 510(k) K182805
  2. Cleared FDA 510(k) K192737
  3. Cleared FDA 510(k) K230753
  4. Listed FDA GUDID 08800003027057
  5. Cleared FDA 510(k) K260462
  6. Registered EUDAMED B-08800003027057

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  • Withdrawn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
RCT800, RBS-RS01
Primary DI / UDI-DI
08800003027057
Basic UDI-DI
B-08800003027057
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 (K182805)

and 5 more cleared under K182805

Cleared under the same submission (K192737)

and 1 more cleared under K192737

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)