A View 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 A View Lcs.

Pre-market Notification Details

Device IDK201710
510k NumberK201710
Device Name:A View 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
ContactHye Yi Park
CorrespondentHye Yi 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 Received2020-06-23
Decision Date2020-10-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800025300084 K201710 000

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