FDA 510(k) Application Details - K163619

Device Classification Name	More FDA Info for this Device
510(K) Number	K163619
Device Name	SIGNA PET/MR
Applicant	GE Medical Systems, LLC 3200 N. Grandview Blvd. Waukesha, WI 53188 US Other 510(k) Applications for this Company
Contact	Janice M. Sich Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2016
Decision Date	02/14/2017
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