AVIEW

System, Image Processing, Radiological

Coreline Soft Co., Ltd

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

Pre-market Notification Details

Device IDK200714
510k NumberK200714
Device Name:AVIEW
ClassificationSystem, Image Processing, Radiological
Applicant Coreline Soft Co., Ltd 4, 5F (Yeonnam-dong) 49, World Cup Buk-ro-6-gil, Mapo-gu Seoul,  KR 03391
ContactHyeyi Park
CorrespondentHyeyi Park
Coreline Soft Co., Ltd 4, 5F (Yeonnam-dong) 49, World Cup Buk-ro-6-gil, Mapo-gu Seoul,  KR 03391
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-18
Decision Date2020-08-26

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