FDA 510(k) Application Details - K103429

Device Classification Name	More FDA Info for this Device
510(K) Number	K103429
Device Name	BIOGRAPH MMR
Applicant	SIEMENS MEDICAL SOLUTIONS USA INC. 810 INNOVATION DRIVE KNOXVILLE, TN 37932 US Other 510(k) Applications for this Company
Contact	ALAINE MEDIO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2010
Decision Date	06/08/2011
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