A View LCS
Coreline Soft Co., Ltd.AView LCS by Coreline Soft Co., Ltd. is a medical software tool that helps clinicians review, analyze, and report on thoracic CT scans. It automatically detects and measures lung nodules, calculates malignancy risk, supports follow-ups with nodule matching, and generates diagnostic reports. This improves the accuracy and efficiency of lung nodule assessment and lung cancer screening.
Intended Use
Intended for the review, analysis, and reporting of thoracic CT images to characterize lung nodules including size, volume, malignancy risk, and more, over single or multiple studies. Integrates with FDA-cleared CAD for automatic nodule detection.
Technology
Software uses deep learning algorithms for lung and lobe segmentation, semi-automatic nodule measurement (segmentation), volumetric and 3D measurements, cancer risk calculation based on PANCAN model, and CAD integration for automatic nodule detection. Features include automated nodule matching for follow-up, Lung-RADS categorization, and report generation.
Performance
No clinical study was required due to equivalence with the predicate. Nonclinical testing included extensive software verification and validation such as unit tests, system tests, and performance tests. The device passed all pre-defined criteria ensuring functionality, reliability, and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/23/2020
3 months - 2
FDA Approval
10/16/2020
Other devices from Coreline Soft Co., Ltd.
- AVIEW CAC2024 • 510K
- AVIEW Lung Nodule CAD2023 • 510K
- AVIEW2022 • 510K
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