InferRead Lung CT.AI
Infervision Medical Technology Co., Ltd.InferRead Lung CT.AI is an AI-powered software tool designed to assist radiologists in detecting and analyzing pulmonary nodules 4mm or larger on chest CT scans of asymptomatic patients aged 55 and older. It provides automatic detection, segmentation, and tracking of nodules over time, helping clinicians identify, measure, and localize lung nodules efficiently. This tool supports early lung nodule detection and monitoring, aiding in lung cancer screening and diagnosis.
Intended Use
InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules ≥ 4mm during the review of CT examinations of the chest on an asymptomatic population ≥ 55 years old. It requires both lungs be in the field of view and provides adjunctive information, not intended to be used without the original CT series.
Technology
InferRead Lung CT.AI uses deep learning technology for automatic detection, segmentation, measurement, and localization of pulmonary nodules on CT scans. It can be deployed on local healthcare facility systems or cloud platforms and overlays CADe marks on original CT images without modifying them. It includes functions for nodule follow-up comparison, nodule density quantification (HU), lobar localization, and registration between current and prior scans.
Performance
Performance testing included validation of nodule detection and segmentation against predicate devices, and standalone tests for nodule registration (match rate 0.97), lobar localization accuracy (0.957), and lung lobe segmentation (Dice coefficient 0.966). Non-clinical testing confirmed compliance with IEC 62304, ISO 14971, and cybersecurity standards. Verification and validation activities demonstrated the device meets acceptance criteria and maintains safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/28/2024
1 year, 2 months - 2
FDA Approval
5/16/2025
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