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, Mobile
510(k) Number K183388
Device Name JADE Mobile X-Ray
Applicant
DRGEM Corporation
7f, E-B/D Gwangmyeong Techno-Park 60, Haan-Ro
Gwangmyeong-Si,  KR 14322
Applicant Contact Ki-Nam Yang
Correspondent
O Tech, Inc.
8317 Belew Dr.
Mckinney,  TX  75071
Correspondent Contact Carl Alletto
Regulation Number892.1720
Classification Product Code
IZL  
Date Received12/06/2018
Decision Date 02/05/2019
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
-
-