FDA 510(k) Application Details - K970627

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K970627
Device Name	System, Tomography, Computed, Emission
Applicant	SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES, IL 60195-7372 US Other 510(k) Applications for this Company
Contact	PAUL G ORIS Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/1997
Decision Date	09/04/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review