AVIEW LCS
Coreline Soft Co., LtdAVIEW LCS by Coreline Soft Co., Ltd. is a diagnostic software tool that reviews, analyzes, and reports on thoracic CT images to help clinicians characterize lung nodules. It automatically measures nodule size, volume, density, and growth over time, integrates with FDA-cleared CAD for nodule detection, and provides lung cancer risk scoring and standardized Lung-RADS categorization. This helps clinicians detect, monitor, and manage lung nodules more accurately and efficiently.
Intended Use
Intended for review, analysis, and reporting of thoracic CT images to characterize lung nodules in single or multiple studies, including nodule type, location, size, volume, HU values, mass, volumetric measures, volume doubling time, and Lung-RADS classification.
Technology
Semi-automatic nodule measurement (segmentation), maximal plane, 3D and volumetric measurements; integration with FDA-cleared Mevis CAD for automatic detection; cancer risk calculation using PANCAN model; Lung-RADS scoring; follow-up with nodule matching and volume doubling time calculation; deep learning based lung and lobe segmentation.
Performance
Nonclinical testing including unit, system, and integration tests were performed. Software verification and validation confirmed functionality, performance, and reliability. Accuracy of nodule segmentation, matching, risk calculation (PANCAN), volume doubling time, and Lung-RADS calculation was confirmed. Auto-segmentation algorithm was validated on Korean and NLST datasets with expert review and dice similarity coefficients.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/21/2019
5 months - 2
FDA Approval
5/5/2020
Other devices from Coreline Soft Co., Ltd
- AVIEW CAC2024 • 510K
- AVIEW Lung Nodule CAD2023 • 510K
- AVIEW2022 • 510K
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