FDA 510(k) Application Details - K132302

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K132302
Device Name	System, Image Processing, Radiological
Applicant	VIEWORKS CO., LTD. 1515 E. KATELLA AVENUE UNIT 2115 ANAHEIM, CA 92805 US Other 510(k) Applications for this Company
Contact	Priscilla Chung 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	07/24/2013
Decision Date	09/12/2013
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