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 System, Image Processing, Radiological
510(k) Number K150761
Device Name Ez3D-i/E3
Applicant
Ewoosoft Co., Ltd.
S-402, 231 Pangyoyeok-Ro
Bundang-Gu
Seongnam,  KR 463-400
Applicant Contact Young Seok Kim
Correspondent
LK Consulting Group USA, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/23/2015
Decision Date 06/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-