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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 Triage And Notification Software
510(k) Number K233247
Device Name Heuron ICH
Applicant
Heuron Co., Ltd.
10F, C, 150, Yeongdeungpo-ro, Yeongdeungpo-gu
Seoul,  KR 07292
Applicant Contact Inah Jeong
Correspondent
Hogan Lovells US LLP
Columbia Square 555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2080
Classification Product Code
QAS  
Date Received09/28/2023
Decision Date 05/15/2024
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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