InferRead Lung CT.AI

Lung Computed Tomography System, Computer-aided Detection

Beijing Infervision Technology Co.,Ltd.

The following data is part of a premarket notification filed by Beijing Infervision Technology Co.,ltd. with the FDA for Inferread Lung

Pre-market Notification Details

Device IDK192880
510k NumberK192880
Device Name:InferRead Lung CT.AI
ClassificationLung Computed Tomography System, Computer-aided Detection
Applicant Beijing Infervision Technology Co.,Ltd. Haidian District Beijing,  CN 100085
ContactChao Tang
CorrespondentMatt Deng
Mid-Link Consulting Co.,Ltd 1900 Market St. 8th Floor Philadelphia,  PA  19103
Product CodeOEB  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-09
Decision Date2020-07-02

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