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 |
|