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FDA-cleared K192880

InferRead Lung CT.AI

Beijing Infervision Technology Co.,Ltd.

Authorized purpose: Computer-assisted reading aid for radiologists detecting pulmonary nodules during review of chest CT examinations in an asymptomatic population; both lungs must be in the field of view, and the original CT series must remain available.

Modality
CT/CTA
Anatomy
Chest; pulmonary nodules in both lungs
Decision
2020-07-02