FDA 510(k) Application Details - K251520

Device Classification Name	More FDA Info for this Device
510(K) Number	K251520
Device Name	Cios Alpha; Cios Flow
Applicant	Siemens Medical Solutions USA, Inc 40 Liberty Boulevard Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Patricia Jones Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2025
Decision Date	07/09/2025
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