A View LCS

FDA 510(k) K201710 · Coreline Soft Co., Ltd.

Substantially Equivalent

510(k) numberK201710

Submission

Device name
A View LCS
Applicant
Coreline Soft Co., Ltd.
Seoul, KR
Received
June 23, 2020
Decision date
October 16, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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More from Avara Software

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K221592AVIEW Lung Nodule CADOEB · Traditional 02/24/2023SE
K214036AviewQIH · Traditional 12/23/2022SE
K220408Aview RT AcsQKB · Traditional 11/10/2022SE
K200714AviewLLZ · Traditional 08/26/2020SE
K193220Aview LCSLLZ · Traditional 05/05/2020SE
K192040AVIEW ModelerLLZ · Traditional 12/20/2019SE

Questions and answers

When was A View LCS cleared by the FDA?

A View LCS (K201710) received a 510(k) decision of Substantially Equivalent on October 16, 2020, 115 days after the submission was received.

What is the product code of K201710?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.