AVIEW LCS

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 Lcs.

Pre-market Notification Details

Device IDK193220
510k NumberK193220
Device Name:AVIEW LCS
ClassificationSystem, Image Processing, Radiological
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 CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-21
Decision Date2020-05-05

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