A View LCS

Coreline Soft Co., Ltd. · K201710 · 2020-10-16

A View LCS is an AI-enabled medical device from Coreline Soft Co., Ltd., listed by FDA (510(k), K201710) with a decision date of 2020-10-16. Review panel: Radiology.

FDA submission numberK201710
Pathway510(k)
CompanyCoreline Soft Co., Ltd.
Review panel (specialty)Radiology
FDA decision date2020-10-16
DecisionSubstantially Equivalent
Product codeLLZ
ClassificationSystem, Image Processing, Radiological
Device class2
Regulation number892.2050
Review time (calendar days)115
Applicant countryKR

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.