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Vieworks

xrayimaging.vieworks.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN KR-MF-000020017

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

60UDI-DI device records

Class IIa 21Class IIb 38IVD A 1

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 30 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

6registered device records

Class IIa 4Class IIb 2

BRBrazilANVISA

8registered devices

Class II 8

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

10 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union60 raw hits, 0 excluded, 60 confirmed

United States30 registration records, 21 510(k), 0 PMA

United Kingdom6 confirmed, 0 excluded

Brazil8 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: VIEWORKS CO., LTD. · Vieworks Co., Ltd. · VIEWORKS CO. LTD · Vieworks CO., LTD

Regulatory identity

EU manufacturer SRN: KR-MF-000020017
EU authorised representative: Vieworks EU GmbH
UK responsible person: CMC Medical Devices LTD
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

FDA 510(k) clearances by year

12007

12008

12009

12012

32013

32016

12017

12018

12019

12020

22022

12024

22025

22026

FDA listed device types

System, Image Processing, Radiological 1Full Field Digital, System, X-Ray, Mammographic 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809394330357	VIVIX-M 1824S	Class IIb
EU	08809394330593	VIVIX-S 3643FW	Class IIb
EU	08809394330289	VIVIX-S 1751S	Class IIb
EU	08809394330517	VIVIX-M 2430D	Class IIb
UK	40866	Slimpac II Plus	Class IIb
UK	40866	VXvue	Class IIa
UK	61108	VIVIX-D 1717G	Class IIb
US	K260820	VIVIX-S 4386W (FXRD-4386WA)	2026-06-18
US	K254092	Bellalun 2D (VDMS-1000S)	2026-05-28
US	K251410	VXvue	2025-11-04
BR	80102519113	Detector Digital de Raios-X para Mamografia Vieworks	Class II
BR	80497209005	DETECTOR PARA SISTEMAS DE RADIOGRAFIA DIGITAL	Class II
BR	10369019001	Sistema para Radiografia Digital (DR)	Class II
CA	80594	DIGITAL X-RAY IMAGE DETECTOR	Class II

Vieworks

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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