InferRead Lung CT.AI
Beijing Infervision Technology Co.,Ltd.InferRead Lung CT.AI is software that helps radiologists detect lung nodules in chest CT scans. It uses AI algorithms to identify and mark nodules, providing measurements and characterization to aid diagnosis, specifically targeting an asymptomatic population. The software integrates with existing PACS systems and assists clinicians by enhancing nodule detection sensitivity and reducing interpretation times.
Intended Use
InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population. Requires both lungs 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 a Browser/Server architecture provided as Software as a Service (SaaS). It integrates algorithm logic and database on the same server, can accept chest CT images from PACS, RIS, or direct from CT scanners. The software analyzes images, provides output annotations of lung nodules which can be viewed using existing PACS workstations. The system consists of modules for image reception, predictive processing (deep learning server), image storage, and display.
Performance
Performance testing included unit, integration, and system software tests, measurement validation on phantom and clinical data, and standalone performance testing on lung cancer screening CT scans showing similar sensitivity and false positive rates compared to a predicate device. Clinical multi-reader multi-case (MRMC) study with 10 radiologists and 249 scans demonstrated significantly improved nodule detection accuracy and reduced reading times using the device, proving it safe and effective.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/9/2019
8 months - 2
FDA Approval
7/2/2020
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