FDA 510(k) Application Details - K042646

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K042646
Device Name	System, X-Ray, Angiographic
Applicant	SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY MALVERN, PA 19355-1406 US Other 510(k) Applications for this Company
Contact	ANA LADINO Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2004
Decision Date	10/19/2004
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	N
Expedited Review