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 K103238
Device Name 1.5T OPTIMA MR430S
Applicant
GE MEDICAL SYSTEMS, LLC
301 BALLARDVALE STREET
SUITE 4
WILMINGTON,  MA  01887
Applicant Contact NORMA LEMAY
Correspondent
GE MEDICAL SYSTEMS, LLC
301 BALLARDVALE STREET
SUITE 4
WILMINGTON,  MA  01887
Correspondent Contact NORMA LEMAY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/02/2010
Decision Date 02/11/2011
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
-
-