FDA 510(k) Application Details - K042605

Device Classification Name	Colon Computed Tomography System, Computer Aided Detection   More FDA Info for this Device
510(K) Number	K042605
Device Name	Colon Computed Tomography System, Computer Aided Detection
Applicant	SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 ERLANGEN 91052 DE Other 510(k) Applications for this Company
Contact	RUDIGER KORNER 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	09/24/2004
Decision Date	10/08/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	Y
Expedited Review