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FDA 510(k)

InferRead Lung CT.AI

K-Number: K192880 · 2020-07-02

ApplicantBeijing Infervision Technology Co., Ltd.
Decision Date2020-07-02
Product CodeOEB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

InferRead Lung CT.AI is a medical device manufactured by Beijing Infervision Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-07-02 under approval number K192880. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InferRead Lung CT.AI?

InferRead Lung CT.AI is a medical device that received FDA 510(k) clearance on 2020-07-02. It is manufactured by Beijing Infervision Technology Co., Ltd.. The 510(k) number is K192880.

When was InferRead Lung CT.AI approved by the FDA?

InferRead Lung CT.AI received FDA 510(k) clearance on 2020-07-02, under approval number K192880.

What company makes InferRead Lung CT.AI?

InferRead Lung CT.AI is manufactured by Beijing Infervision Technology Co., Ltd..

What is the FDA product code for InferRead Lung CT.AI?

The FDA product code for InferRead Lung CT.AI is OEB.

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Official Source

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