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Aview Lcs

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193220

by Coreline Soft Co., Ltd.

Identifiers

510(k) Number
K193220 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Aview Lcs is a software device designed for the review, analysis, and reporting of thoracic CT images. It assists healthcare professionals by characterizing lung nodules, including their type, location, and measurements such as major axis, minor axis, and estimated effective diameter.

This device supports the review of analysis information within the interpretation environment, including Worklist, GSPS, and Report. It is authorized via FDA 510k clearance under K193220.

Frequently asked questions

What is the primary function of the Aview Lcs software?

Aview Lcs is designed to assist healthcare professionals in the review, analysis, and reporting of thoracic CT images. It specifically aids in the characterization of lung nodules by providing measurements such as major axis, minor axis, and estimated effective diameter, as well as identifying nodule type and location.

How does the software integrate into a clinical workflow?

The device supports the review of analysis information directly within the interpretation environment. It is compatible with standard clinical workflows, including Worklist, GSPS, and Report, allowing for seamless integration when analyzing thoracic CT data.

What is the regulatory status of Aview Lcs?

Aview Lcs has received FDA 510k clearance under K193220. This indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices for its intended use in thoracic CT image analysis.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: aview LCS : Lung Nodule AI Software | LCS | Coreline Soft, AVIEW LCS+ - Coreline Soft, aview LCS Plus : Chest CT Multi-Disease Analysis Software | LCS Plus ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Coreline Soft Co., Ltd.

Sources (1)

  • FDA 510(k) K193220 24 fields · synced Sep 26, 2026