FDA 510(k) Application Details - K083591

Device Classification Name	System, Simulation, Radiation Therapy   More FDA Info for this Device
510(K) Number	K083591
Device Name	System, Simulation, Radiation Therapy
Applicant	IKOETECH, LLC. 6223 RICHMOND AVE., SUITE 303 HOUSTON, TX 77057 US Other 510(k) Applications for this Company
Contact	HUIMIN CHAO 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	12/04/2008
Decision Date	12/29/2008
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