FDA 510(k) Application Details - K193283

Device Classification Name	More FDA Info for this Device
510(K) Number	K193283
Device Name	AI-Rad Companion Prostate MR
Applicant	Siemens Medical Solutions USA Inc. 40 Liberty Blvd. Mail Code 65-3 Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Lauren Bentley 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	11/27/2019
Decision Date	07/30/2020
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