FDA 510(k) Application Details - K213706

Device Classification Name	More FDA Info for this Device
510(K) Number	K213706
Device Name	AI-Rad Companion Brain MR
Applicant	Siemens Healthcare GmBh 40 Liberty Blvd. Mail Code 65-1 Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Kira Kuzmenchuk 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	11/24/2021
Decision Date	04/15/2022
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