FDA 510(k) Application Details - K200474

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K200474
Device Name	System, Tomography, Computed, Emission
Applicant	Siemens Medical Solutions USA, Inc. 2501 N Barrington Road Hoffman Estates, IL 60192-2061 US Other 510(k) Applications for this Company
Contact	Cynthia Busch 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	02/26/2020
Decision Date	03/20/2020
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