FDA 510(k) Application Details - K042793

Device Classification Name	More FDA Info for this Device
510(K) Number	K042793
Device Name	ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
Applicant	SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY E-50 MALVERN, PA 19355 US Other 510(k) Applications for this Company
Contact	DEBBIE PEACOCK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2004
Decision Date	10/29/2004
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