FDA 510(k) Application Details - K121854

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K121854
Device Name	System, X-Ray, Stationary
Applicant	BEIJING SINOPHARM HUNDRIC MEDILINE INFO. TECH. CO. P.O. BOX 237-023 SHANGHAI 200237 CN Other 510(k) Applications for this Company
Contact	Diana Hong Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2012
Decision Date	08/22/2012
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