FDA 510(k) Application Details - K201195

Device Classification Name	More FDA Info for this Device
510(K) Number	K201195
Device Name	syngo.via MI Workflows, syngo MBF
Applicant	Siemens Medical Solutions USA, Inc. 2501 N. 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	05/04/2020
Decision Date	11/18/2020
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