• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K181003
Device Name VIVIX-S 1717V
Vieworks Co., Ltd.
(Gwanyang-dong) 41-3, Burim-ro 170beon-gil,
Anyang-si,  KR 431-060
Applicant Contact Jordin Kim
LK Consulting Group USA, Inc.
690 Roosevelt
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number892.1680
Classification Product Code
Date Received04/16/2018
Decision Date 05/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No