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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lung Computed Tomography System, Computer-Aided Detection
510(k) Number K221592
Device Name AVIEW Lung Nodule CAD
Applicant
Coreline Soft Co.,Ltd.
4,5F(Yeonnam-dong), 49, World Cup buk-ro 6-gil, Mapo-gu
Seoul,  KR 03991
Applicant Contact Hyeyi Park
Correspondent
Coreline Soft Co.,Ltd.
4,5F(Yeonnam-dong), 49, World Cup buk-ro 6-gil, Mapo-gu
Seoul,  KR 03991
Correspondent Contact Hyeyi Park
Regulation Number892.2050
Classification Product Code
OEB  
Subsequent Product Code
LLZ  
Date Received06/02/2022
Decision Date 02/24/2023
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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