FDA 510(k) Application Details - K123068

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K123068
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	GE MEDICAL SYSTEMS, LLC 301 BALLARDVALE STREET SUITE 4 WILMINGTON, MA 01887 US Other 510(k) Applications for this Company
Contact	YUAN MA Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	LNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2012
Decision Date	11/13/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review