FDA 510(k) Application Details - K163331

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K163331
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	GE Medical Systems, LLC 3200 Grandview Blvd Waukesha, WI 53188 US Other 510(k) Applications for this Company
Contact	Mary A. Mayka 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	11/28/2016
Decision Date	03/17/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review