FDA 510(k) Application Details - K222428

Device Classification Name	More FDA Info for this Device
510(K) Number	K222428
Device Name	Syngo Dynamics (Version VA40F)
Applicant	Siemens Medical Solutions USA, Inc. 400 W. Morgan Road Ann Arbor, MI 48108 US Other 510(k) Applications for this Company
Contact	Jiayan Liu 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	08/11/2022
Decision Date	11/14/2022
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