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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 K233211
Device Name AVIEW CAC
Applicant
Coreline Soft Co., Ltd.
4, 5F (Yeonnam-dong), 49 World Cup buk-ro 6-gil,
Mapo-gu
Seoul,  KR
Applicant Contact Hye Yi Park
Correspondent
Coreline Soft Co., Ltd.
4, 5F (Yeonnam-dong), 49 World Cup buk-ro 6-gil,
Mapo-gu
Seoul,  KR
Correspondent Contact Hyeyi Park
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
JAK  
Date Received09/28/2023
Decision Date 03/29/2024
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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