FDA 510(k) Application Details - K140920

Device Classification Name	Colon Computed Tomography System, Computer Aided Detection   More FDA Info for this Device
510(K) Number	K140920
Device Name	Colon Computed Tomography System, Computer Aided Detection
Applicant	SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY MALVEN, PA 19355 US Other 510(k) Applications for this Company
Contact	KIMBERLY MANGUM Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	NWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2014
Decision Date	12/03/2014
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