FDA 510(k) Application Details - K200213

Device Classification Name	More FDA Info for this Device
510(K) Number	K200213
Device Name	Biograph mMR with syngo MR E11P-AP01 system software
Applicant	Siemens Medical Solutions, USA, Inc. 40 Liberty Boulevard Mailcode 65-1A Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Cordell L. Fields Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2020
Decision Date	05/11/2020
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