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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 K233457
Device Name RUS
Applicant
Hutom Inc.
6F, 279, Dongmak-ro, Mapo-gu
Seoul,  KR 04151
Applicant Contact Heejoo Yun
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  
Date Received10/20/2023
Decision Date 07/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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