AVIEW is a medical imaging software by Coreline Soft that helps clinicians analyze CT scans of the lungs and heart. It automatically segments lung structures, characterizes lung nodules with detailed measurements, and provides calcium scoring of coronary arteries to assess cardiovascular risk. It integrates with AI-based CAD tools and offers cloud and mobile access, making it easier and faster for doctors to diagnose lung and heart conditions.
Intended Use
AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets to support quantitative analysis by image segmentation and reporting tools, including lung nodule characterization and coronary artery calcium scoring for adult patients.
Technology
AVIEW is a PC-installable software using DICOM 3.0 for image input and communication. It uses deep-learning algorithms for fully automatic segmentation of lungs, lobes, airways, and coronary arteries to quantify structures, characterize lung nodules with volumetric and density measurements, perform nodule matching and Lung-RADS classification, and compute coronary calcium scores.
Performance
Nonclinical performance tests included functional unit tests, system tests, and performance tests validating segmentation accuracy, nodule measurement and matching, Lung-RADS calculation, coronary calcium scoring, lung fissure completeness assessment, and airway segmentation. The device passed all software verification tests and demonstrated substantial equivalence to predicate devices, negating the need for clinical studies.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/23/2021
1 year - 2
FDA Approval
12/23/2022
Other devices from Coreline Soft Co.,Ltd.
- AVIEW CAC2024 • 510K
- AVIEW Lung Nodule CAD2023 • 510K
- AVIEW RT ACS2022 • 510K
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