Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Display, Diagnostic Radiology
510(k) Number K161057
Device Name Diagnostic Imaging Color LCD Monitor
Applicant
NEC DISPLAY SOLUTIONS LTD.
4-28, MITA 1-CHOME, MINATO-KU
TOKYO,  JP
Applicant Contact SATORU KOTANI
Correspondent
TOP VICTORY ELECTRONICS (TAIWAN) CO., LTD.
10F, NO. 230, LIANCHENG RD. ZHONGHE DIST.
NEW TAIPEI CITY,  TW 23559
Correspondent Contact DAVID CHENG
Regulation Number892.2050
Classification Product Code
PGY  
Date Received04/14/2016
Decision Date 05/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-