FDA 510(k) Application Details - K132045

Device Classification Name	System, Simulation, Radiation Therapy   More FDA Info for this Device
510(K) Number	K132045
Device Name	System, Simulation, Radiation Therapy
Applicant	GE HUNGARY KFT 3000 N GRANDVIEW DIVISION: DBA GE HEALTHCARE WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	STEPHEN SLAVENS 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	07/02/2013
Decision Date	09/04/2013
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