FDA 510(k) Application Details - K211179

Device Classification Name	More FDA Info for this Device
510(K) Number	K211179
Device Name	InferRead CT Stroke.AI
Applicant	Infervision Medical Technology Co., Ltd. Room B401, 4th Floor, Building 1, No. 12 Shangdi Information Road, Haidian District Beijing 100085 CN Other 510(k) Applications for this Company
Contact	Xiaoyan Fan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2021
Decision Date	08/12/2021
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