FDA 510(k) Application Details - K240554

Device Classification Name	Lung Computed Tomography System, Computer-Aided Detection   More FDA Info for this Device
510(K) Number	K240554
Device Name	Lung Computed Tomography System, Computer-Aided Detection
Applicant	Infervision Medical Technology Co., Ltd. Room B401, 4th Floor, Building 1, No.12 Shangdi Information Road, Haidian District Beijing CN Other 510(k) Applications for this Company
Contact	Matt Deng 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	02/28/2024
Decision Date	05/16/2025
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