FDA 510(k) Application Details - K192890

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K192890
Device Name	System, Image Processing, Radiological
Applicant	SentiAR, Inc 212 Kingshighway Blvd., Suite 115 Mailbox 28 St. Louis, MO 63108 US Other 510(k) Applications for this Company
Contact	Berk Tas Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2019
Decision Date	09/18/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review