FDA 510(k) Application Details - K232305

Device Classification Name	More FDA Info for this Device
510(K) Number	K232305
Device Name	AI-Rad Companion Brain MR
Applicant	Siemens Medical Solutions U.S.A. 40 Liberty Blvd. Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Kira Morales 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	08/01/2023
Decision Date	10/23/2023
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