FDA 510(k) Application Details - K171977

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K171977
Device Name	System, Image Processing, Radiological
Applicant	Hinacom Software and Technology, Ltd Suite B301, R&D Plaza, Tsinghua science park, Haidian Distr. Beijing 100084 CN Other 510(k) Applications for this Company
Contact	Yi Isabelle Sun 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	06/30/2017
Decision Date	08/02/2018
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