FDA 510(k) Application Details - K111861

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K111861
Device Name	System, Image Processing, Radiological
Applicant	SIEMENS MEDICAL SYSTEMS USA 53 VALLEY STREAM PARKWAY MALVERN, PA 19355 US Other 510(k) Applications for this Company
Contact	NADIA SOOKDEO 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	06/30/2011
Decision Date	01/06/2012
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