FDA 510(k) Application Details - K150767

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K150767
Device Name	Accelerator, Linear, Medical
Applicant	GUANGZHOU RAYDOSE SOFTWARE TECHNOLOGY., LLC NO.850 EAST DONGFENG ROAD, GUANGZHOU CITY, GUANGDONG PROVINCE , P.R. CHINA, ROOM 502, GLORIOUS TOWER GUANGZHOU 510060 CN Other 510(k) Applications for this Company
Contact	DENNIS DONG Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2015
Decision Date	08/17/2015
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