FDA 510(k) Application Details - K251671

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K251671
Device Name	System, Tomography, Computed, Emission
Applicant	Siemens Medical Solutions USA, Inc. 2501 North Barrington Road Hoffman Estates, IL 60192 US Other 510(k) Applications for this Company
Contact	Clayton Ginn 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	05/30/2025
Decision Date	07/03/2025
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