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, X-Ray, Stationary
510(k) Number K142930
Device Name Exam Vue DR
Applicant
Jpi Healthcare Co, Ltd.
Woolim E-Biz Center #608, 170-5
Kuro 3-Dong, Kuro_Gu,  KR 152-769
Applicant Contact Wonsik (Stanley) Youn
Correspondent
Jpi Healthcare Solutions, Inc.
52 Newtown Plz.
Plainview,  NY  11803
Correspondent Contact William Little
Regulation Number892.1680
Classification Product Code
KPR  
Date Received10/09/2014
Decision Date 04/17/2015
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
-
-