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Vivix-S 1717V

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

Ref FXRD-1717VAModel VIVIX-S 1717V, VIVIX-S 1751S, VIVIX-S 4386W Product code MQBEMDN Z11031180

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number880939433VIVIXS1717V2Y Basic UDI-DIDate4 Aug 2023RegisteredStatusActive
European UnionCE/MDR EUDAMED Number880939433VIVIXS1717V2Y Basic UDI-DIDate4 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08809394330241 UDI-DIDate31 May 2019ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK181003 Date15 May 2018IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Generic Name
Indirect flat panel x-ray detector
Device Name
Digital Imaging System
Model / Reference
VIVIX-S 1717V, VIVIX-S 1751S, VIVIX-S 4386W, FXRD-1717VA
Primary DI / UDI-DI
08809394330241
Basic UDI-DI
880939433VIVIXS1717V2Y, B-08809394330241
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 IIa EUDAMED
Class IIb 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 IIa
Class IIb
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
  • Serial 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
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (4)

  • EUDAMED 5324ec7f-1c79-492d-9ed5-22943f7c0505 61 fields · synced 24 Oct 2026
  • EUDAMED 08809394330241|B-08809394330241 61 fields · synced 19 May 2026
  • FDA UDI ade1a44b-8587-4126-80e2-dbacd9eed7b1 35 fields · synced 30 May 2026
  • FDA 510(k) K181003 1 fields · synced 18 May 2026