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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 K243689
Device Name AVIEW
Applicant
Coreline Soft Co., Ltd.
12, Donggyo-ro 19-gil, Mapo-gu
Seoul,  KR
Applicant Contact Park Hyeyi
Correspondent
Coreline Soft Co., Ltd.
12, Donggyo-ro 19-gil, Mapo-gu
Seoul,  KR
Correspondent Contact Hyeyi Park
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
JAK  
Date Received11/29/2024
Decision Date 03/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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