FDA 510(k) Application Details - K113034

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K113034
Device Name	System, X-Ray, Angiographic
Applicant	GE HEALTHCARE 9900 Innovation Drive Wauwatosa, WI 53226 US Other 510(k) Applications for this Company
Contact	CAROL ALLOIAN Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/11/2011
Decision Date	12/13/2011
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