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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
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