BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    VIEWORKS CO., LTD.

    Reg #: 3006013411 · FEI: 3006013411 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    44
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    VIEWORKS CO., LTD.
    Registration Number
    3006013411
    FEI Number
    3006013411
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    41-3, Burim-ro 170beon-gil, Dongan-gu
    City
    Anyang-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K241113

    Owner / Operator

    Firm Name
    Vieworks Co., Ltd.
    Operator Number
    10024523
    Address
    41-3, Burim-ro 170beon-gil, Dongan-gu
    City
    Anyang-si
    State
    Gyeonggi
    Postal Code
    14055
    Country
    KR
    Correspondent
    Serin Park

    US Agent

    Business Name
    Vieworks America Ltd.
    Contact Name
    Peter Lee
    Address
    970 Woodlands Pkwy
    City
    Vernon Hills
    State
    IL
    ZIP
    60061
    Country
    US
    Email
    [email protected]
    Phone
    847 6134338

    Products

    Device Name Product Code
    Full Field Digital, System, X-Ray, Mammographic MUE
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, Image Processing, Radiological LLZ

    Proprietary Names

    VIVIX-M VXvue PRO 3543T PRO 3543TC PRO 4343FC PRO 4343F Saturn 8000 ViVIX-S VIVIX-S 1012N VIVIX-S 1717V ViVIX-S Wireless PRO 3543 PRO 3543C QXLink VIVIX-S 1717N VIVIX-S F series F3025-AW VIVIX-S FW VIVIX-S 4386W Cuattro ONE L8643-AWV FXRD-1751SA FXRD-1751SB VIVIX-S 1751S Cuattro ONE Long Format Digital Radiography Carestream DRX-L Detector FXRD-1417N VWD-1012P VWD-1417A VIVIX-S VW S3025-AW XD 14 XD+10 XD 17 XD+17 XD+14 XD 10 S3025-AWM VIVIX-S V series VWD-1417P VWD-1717A RXsensor VWD-1717P VWD-1012A

    Establishment Types

    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