Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006013411

FEI Number

3006013411

Entity Name

VIEWORKS CO., LTD.

City/State/Country

Anyang-si Gyeonggi, KR

Establishment Address

41-3, Burim-ro 170beon-gil, Dongan-gu, Anyang-si Gyeonggi 14055, KR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Vieworks Co., Ltd. (Owner Number: 10024523)

Owner / Operator Contact Address

41-3, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, KR-41 14055, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220239

PMA Number

N/A

All Registered Proprietary Names

VIVIX-M VXvue PRO 3543T PRO 3543TC PRO 4343FC PRO 4343F Saturn 8000 ViVIX-S VIVIX-S 1012N Saturn 8000 VXvue VIVIX-S 1717V Saturn 8000 ViVIX-S Wireless PRO 3543 PRO 3543C Saturn 8000 QXLink VIVIX-S 1717N Saturn 8000 Saturn 8000 VIVIX-S F series F3025-AW VIVIX-S FW VIVIX-S 4386W Cuattro ONE L8643-AWV

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2025-01-17
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2013-01-19
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2016-03-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-04-02
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-05-16
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2013-02-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-08-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2016-03-02
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-07-21
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-09-14

Official Correspondent

Serin Park

US Agent Details

Peter Lee Business: Vieworks America Ltd. Email: regulatory.us@vieworks.com Phone: (847) 6134338

Related Public Records

Same Entity

Vieworks Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017585294	Vieworks Co., Ltd.	Hwaseong-si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006013411. Last updated year: 2026. Please use registration number 3006013411 when referencing this establishment in official correspondence.