FDA 510(k) Application Details - K251528

Device Classification Name	More FDA Info for this Device
510(K) Number	K251528
Device Name	syngo.via MI Workflows; Scenium; syngo MBF
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	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/2025
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	Traditional
Reviewed By Third Party	N
Expedited Review