FDA 510(k) Application Details - K242551

Device Classification Name	More FDA Info for this Device
510(K) Number	K242551
Device Name	syngo Dynamics (Version VA41D)
Applicant	Siemens Healthcare GmbH Henkestr. 127 Erlangen 91052 DE 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	08/27/2024
Decision Date	04/03/2025
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