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Aview Lung Nodule Cad

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221592

by Coreline Soft Co., Ltd.

Identifiers

510(k) Number
K221592 FDA 510(k)
FDA Product Code
OEB 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)

The Aview Lung Nodule Cad is a Computer-Aided Detection (CAD) software designed to assist radiologists in the detection of pulmonary nodules during the review of CT examinations of the chest. It is intended to be used as an adjunctive second-reader after the radiologist's initial read. The software is validated using non-contrast chest CT and is designed to detect nodules with a diameter of 3-20 mm.

The Aview Lung Nodule Cad is supplied as a software solution and is classified as a Lung Computed Tomography System with Computer-Aided Detection. It has received FDA 510K authorization and is listed with the regulation number 892.2050. The device is intended for use in radiology workflows and screening operations, and its use is restricted to asymptomatic populations.

Frequently asked questions

What is the AVIEW Lung Nodule CAD used for?

The AVIEW Lung Nodule CAD is used to assist radiologists in detecting pulmonary nodules during CT examinations of the chest, as an adjunctive second-reader after the radiologist's initial read.

What type of CT exams is the AVIEW Lung Nodule CAD validated for?

The AVIEW Lung Nodule CAD is validated using non-contrast chest CT exams.

What is the size range of nodules the AVIEW Lung Nodule CAD can detect?

The AVIEW Lung Nodule CAD is designed to detect nodules with a diameter of 3-20 mm.

Is the AVIEW Lung Nodule CAD intended for use in symptomatic or asymptomatic populations?

The AVIEW Lung Nodule CAD is intended for use in asymptomatic populations.

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: CT-Based Medical AI Software | Main (Global) | Coreline Soft, All aview Software | All Software | Coreline Soft, AI Chest CT Analysis & Lung Cancer Screening | Coreline Soft, AVIEW Lung Nodule CAD — OncologyAI Registry, AVIEW Lung Nodule CAD Review: Pricing, FDA Status & Alternatives ...

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) K221592 24 fields · synced Oct 1, 2026