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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K220408
Device Name AVIEW RT ACS
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
QKB  
Date Received02/14/2022
Decision Date 11/10/2022
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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