2 devices · 1 company · 2021 to 2025

Infervision Medical Technology Co., Ltd.: AI-enabled devices on FDA's list

2 devices from Infervision Medical Technology Co., Ltd., 2021 to 2025, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from Infervision Medical Technology Co., Ltd.

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Infervision Medical Technology Co., Ltd. · 2 devices
DecisionDevicePanelProduct codeFDA
InferRead Lung CT.AIK240554 · 510(k)RadiologyOEBdatabase entry
InferRead CT Stroke.AIK211179 · 510(k)RadiologyQASdatabase entry

Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.

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Every device here is authorized for a stated use. See a record read against what it must prove, on your own file.

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