FDA 510(k) Application Details - K200750

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K200750
Device Name	System, Image Processing, Radiological
Applicant	TeraRecon, Inc. 4309 Emperor Blvd., Suite 310 Durham, NC 27703 US Other 510(k) Applications for this Company
Contact	Megha Jain 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	03/23/2020
Decision Date	11/06/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review