qCT LN Quant
Qure.ai TechnologiesqCT LN Quant is a software tool that helps radiologists track, assess, and quantify lung nodules seen in CT scans. It provides volumetric and diameter measurements of user-selected nodules, with 2D and 3D visualizations, and uses AI algorithms to assist in characterizing nodules including measurements like volume doubling time and density. It supports clinical decision-making with integrated risk calculators based on established lung nodule malignancy and management guidelines.
Intended Use
qCT LN Quant is a software device used in the tracking, assessment, and quantitative characterization of detected pulmonary nodules. It analyzes user-selected regions within lung CT to provide volumetric, diameter and morphological analysis in a single study or over multiple thoracic studies. It displays measurements and 2D/3D views of solid pulmonary nodules for evaluation.
Technology
Deep-learning based software that processes non-contrast chest CT scans to semi-automatically segment and quantitatively characterize solid lung nodules ≥6mm. It integrates with PACS systems and provides volumetric, diameter, and density measurements, as well as risk calculators (Brock and Lung-RADS) to aid clinical decision-making.
Performance
Software underwent verification and validation tests per FDA guidance, with unit, integration, regression, and user acceptance testing, showing the device functioned as designed and met acceptance criteria. Clinical performance tested using 118 chest CT scans with ground truth by expert radiologists showed good accuracy of nodule measurements (Median Absolute Normalized Error: Long Axis 11.1%, Short Axis 14.3%, Volume 20.7%).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/18/2024
5 months - 2
FDA Approval
8/16/2024
Other devices from Qure.ai Technologies
- qXR-LN2023 • 510K
- qXR-CTR2023 • 510K
- qXR-PTX-PE2023 • 510K
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