FDA 510(k) Application Details - K113456

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K113456
Device Name	System, Image Processing, Radiological
Applicant	GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) 3144 N GRANDVIEW BLVD, MAIL STOP- W-501 WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	ELIZABETH MATHEW Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2011
Decision Date	06/15/2012
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