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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Prioritization Software For Lesions
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,  KR 06541
Applicant Contact Jiwon Song
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave.
Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number892.2080
Classification Product Code
QFM  
Date Received05/21/2024
Decision Date 11/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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