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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 K214036
Device Name AVIEW
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 Hye Yi Park
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
JAK  
Date Received12/23/2021
Decision Date 12/23/2022
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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