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VXvue

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

Ref VXvue, VXvue Mammo

Product code LLZEMDN Z11031182

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08809394330371 UDI-DIDate16 Sep 2026ListedStatusWithdrawn
United StatesFDA 510(k) 510(k) NumberK251410 Date4 Nov 2025IssuedStatusActive
European UnionCE/MDD EUDAMED NumberB-08809394330371 Basic UDI-DIDate12 Jul 2023RegisteredStatusWithdrawn No longer placed on the EU market

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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Withdrawn
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Withdrawn

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 25 Oct 2026

Trade Name
VXvue EUDAMEDGUDID
VXvue Mammo EUDAMED
Generic Name
Basic x-ray clinical assessment support software
Device Name
Image Acquisition Software
Model / Reference
VXvue, VXvue Mammo
Primary DI / UDI-DI
08809394330371, 08809394330395
Basic UDI-DI
B-08809394330371, B-08809394330395, 880939433VXvue8X
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z11031182 Systems for direct digital radiology (dr) - software accessories
GMDN Term
Basic x-ray clinical assessment support software
Device Class
Class IIb EUDAMED
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
-1192
Software
Market of Registration
France
Belgium
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
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date
Other properties (21)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No

Sources (5)

  • EUDAMED 2e93ee49-8bae-494f-b016-2c207cfc3da7 61 fields · synced 25 Oct 2026
  • EUDAMED 08809394330395|B-08809394330395 61 fields · synced 18 May 2026
  • EUDAMED 08809394330371|880939433VXVUE8X 61 fields · synced 10 Jul 2026
  • FDA UDI aa412d75-d71b-458a-a20b-1d200db43f84 33 fields · synced 23 Oct 2026
  • FDA 510(k) K251410 1 fields · synced 18 May 2026