Infervision Medical Technology Co., Ltd. radiology AI products

FDA-cleared K240554

InferRead Lung CT.AI

Infervision Medical Technology Co., Ltd.

Adjunctive pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2025-05-16

FDA-cleared K211179

InferRead CT Stroke.AI

Infervision Medical Technology Co., Ltd.

InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of Non-Enhanced Head CT images. The device is intended to assist...

Modality: CT/CTA
Anatomy: Brain
Decision: 2021-08-12

Stroke and ICH triage Detection and CADe Acute triage and notification