FDA 510(k) Application Details - K241439

Device Classification Name	More FDA Info for this Device
510(K) Number	K241439
Device Name	VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
Applicant	Vuno Inc. 9F, 479, Gangnam-daero, Seocho-gu Seoul 06541 KR Other 510(k) Applications for this Company
Contact	Jiwon Song Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2024
Decision Date	11/15/2024
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