FDA 510(k) Application Details - K203260

Device Classification Name	More FDA Info for this Device
510(K) Number	K203260
Device Name	syngo.CT Brain Hemorrhage
Applicant	Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 US Other 510(k) Applications for this Company
Contact	Tabitha Estes Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2020
Decision Date	01/28/2022
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