FDA 510(k) Application Details - K133098

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K133098
Device Name	System, Image Processing, Radiological
Applicant	DALIAN SENYINT DIGITAL MEDICAL SYSTEM CO., LTD. 3500 SOUTH DUPONT HIGHWAY DOVER, DE 19901 US Other 510(k) Applications for this Company
Contact	LEON LU Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2013
Decision Date	06/13/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review