FDA 510(k) Application Details - K052345

Device Classification Name	System, Simulation, Radiation Therapy   More FDA Info for this Device
510(K) Number	K052345
Device Name	System, Simulation, Radiation Therapy
Applicant	GE HEALTHCARE 3000 N. GRANDVIEW BLVD WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	LARRY A KROGER Other 510(k) Applications for this Contact
Regulation Number	892.5840   More FDA Info for this Regulation Number
Classification Product Code	KPQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2005
Decision Date	09/14/2005
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	Y
Expedited Review