FDA 510(k) Application Details - K061006

Device Classification Name	System, Simulation, Radiation Therapy   More FDA Info for this Device
510(K) Number	K061006
Device Name	System, Simulation, Radiation Therapy
Applicant	IKOETECH, LLC. 3000 RICHMOND, SUITE 200 HOUSTON, TX 77098 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	04/11/2006
Decision Date	06/05/2006
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