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, nuclear magnetic resonance imaging
510(k) Number K142085
Device Name DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T
Applicant
GE MEDICAL SYSTEMS, LLC
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact JENNY WONG
Correspondent
GE MEDICAL SYSTEMS, LLC
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact JENNY WONG
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/31/2014
Decision Date 09/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-