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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
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