FDA 510(k) Application Details - K242919

Device Classification Name	Lung Computed Tomography System, Computer-Aided Detection   More FDA Info for this Device
510(K) Number	K242919
Device Name	Lung Computed Tomography System, Computer-Aided Detection
Applicant	V5med Inc. 7F., No. 36, Chenggong 12th St., Zhubei City Hsinchu County 302050 TW Other 510(k) Applications for this Company
Contact	Ining Cheng 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	09/24/2024
Decision Date	03/27/2025
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