FDA 510(k) Application Details - K092639

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K092639
Device Name	System, Image Processing, Radiological
Applicant	GE MEDICAL SYSTEMS SCS 3000 NORTH GRANDVIEW BLVD W450 WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	NICOLE LANDREVILLE 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	08/27/2009
Decision Date	12/02/2009
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