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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K231398
Device Name VUNO Med-DeepBrain
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.
Ste. 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received05/15/2023
Decision Date 10/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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