FDA 510(k) Application Details - K050297

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K050297
Device Name	System, X-Ray, Tomography, Computed
Applicant	SIEMENS MEDICAL SOLUTION, INC. USA 51 VALLEY STREAM PKWY. E50 MALVERN, PA 19355 US Other 510(k) Applications for this Company
Contact	DEBRA PEACOCK Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2005
Decision Date	03/01/2005
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