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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
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