FDA 510(k) Application Details - K192880

Device Classification Name	Lung Computed Tomography System, Computer-Aided Detection   More FDA Info for this Device
510(K) Number	K192880
Device Name	Lung Computed Tomography System, Computer-Aided Detection
Applicant	Beijing Infervision Technology Co.,Ltd. Haidian District Beijing 100085 CN Other 510(k) Applications for this Company
Contact	Xiaoyan Fan Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	OEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2019
Decision Date	07/02/2020
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