AVIEW RT ACS

Radiological Image Processing Software For Radiation Therapy

Coreline Soft Co.,Ltd

The following data is part of a premarket notification filed by Coreline Soft Co.,ltd with the FDA for Aview Rt Acs.

Pre-market Notification Details

Device IDK220408
510k NumberK220408
Device Name:AVIEW RT ACS
ClassificationRadiological Image Processing Software For Radiation Therapy
Applicant Coreline Soft Co.,Ltd 4,5F (Yeonnam-dong), 49, World Cup Buk-ro-6-gil, Mapo-gu Seoul,  KR 03991
ContactHyeyi Park
CorrespondentHyeyi Park
Coreline Soft Co.,Ltd 4,5F (Yeonnam-dong), 49, World Cup Buk-ro-6-gil, Mapo-gu Seoul,  KR 03991
Product CodeQKB  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-14
Decision Date2022-11-10

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