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OSCAR Prime

by GENORAY CO., Ltd.

Ref 108

OSCAR Prime (108) is a mobile general-purpose fluoroscopic x-ray system (EU MDR Class IIb; FDA Class II) made by Genoray Co., Ltd., registered in EUDAMED on 13 Apr 2026 (Basic UDI-DI 880924406OSCARKZ), cleared under FDA 510(k) K181943 on 17 Aug 2018 and listed in FDA GUDID since 22 Aug 2018 (UDI-DI 08809244060106), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181943

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880924406OSCARKZ Basic UDI-DI 08809244060106UDI-DIDate13 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809244060106 UDI-DI Date22 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181943 Date17 Aug 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880924406OSCARKZ registered 13 Apr 2026 Active
  • FDA 510(k) K181943 decided 17 Aug 2018 Active
  • FDA GUDID UDI-DI 08809244060106 listed 22 Aug 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181943
  2. Listed FDA GUDID 08809244060106
  3. Registered EUDAMED 880924406OSCARKZ

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  • Withdrawn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
OSCAR Prime EUDAMED
Genoray GUDID
Generic name
Mobile general-purpose fluoroscopic x-ray system, digital
Device name
OSCAR (OSCAR Prime(Unique Start FD), OSCAR Classic (Unique Class))
Model / reference
108 EUDAMED
OSCAR Prime GUDID
Primary DI / UDI-DI
08809244060106
Basic UDI-DI
880924406OSCARKZ
510(k) Number
FDA product code
OWB, JAA
EMDN code
Z11039009 Fluoroscopy devices
GMDN term
Mobile general-purpose fluoroscopic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650
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
108
GUDID
OSCAR Prime
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.

Manufacturer details

EUDAMED SRN
KR-MF-000021014
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)