Skip to content

Vivix-S 2530VW

by Vieworks Co., Ltd. South Korea EUDAMED510(k)GUDID

Ref FXRD-2530VAWModel VIVIX-S VW Series, VIVIX-S FW Series, VIVIX-S VR Series Product code MQBEMDN Z11031180

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-08809394330296 Basic UDI-DIDate12 Jul 2023RegisteredStatusWithdrawn No longer placed on the EU market
European UnionCE/MDD EUDAMED NumberB-08809394330296 Basic UDI-DIDate12 Jul 2023RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number08809394330296 UDI-DIDate6 Oct 2020ListedStatusWithdrawn
United StatesFDA 510(k) 510(k) NumberK120020 Date4 May 2012IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR, CE/MDD Withdrawn
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Trade Name
Vivix-S 2530VW EUDAMED
Vivix-S 2530VAW GUDID
Generic Name
Indirect flat panel x-ray detector
Device Name
Digital Imaging System
Model / Reference
FXRD-2530VAW, VIVIX-S VW Series, VIVIX-S FW Series, VIVIX-S VR Series
Primary DI / UDI-DI
08809394330296
Basic UDI-DI
B-08809394330296, 880939433VIVIXSVW2H
510(k) Number
FDA Product Code
MQB
EMDN Code
Z11031180 Systems for direct digital radiology (dr) - hardware accessories
GMDN Term
Indirect flat panel x-ray detector
Device Class
Class IIb EUDAMED
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1680
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000020017
Authorised representative
Vieworks EU GmbH DE-AR-000052174

Other devices from Vieworks Co., Ltd.

See all devices from Vieworks Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Serial Number
  • Manufacturing Date
Other properties (22)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (4)

  • EUDAMED 968e11be-6d13-41f5-b662-670b213d3626 61 fields · synced 22 Oct 2026
  • EUDAMED 08809394330296|880939433VIVIXSVW2H 61 fields · synced 18 May 2026
  • FDA UDI 3aa964ef-fc1d-40cf-a3f3-7f54f52c4466 34 fields · synced 30 May 2026
  • FDA 510(k) K120020 1 fields · synced 18 May 2026