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FDA 510(k)

InferRead Lung CT.AI

K-Number: K240554 · 2025-05-16

ApplicantInfervision Medical Technology Co., Ltd.
Decision Date2025-05-16
Product CodeOEB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

InferRead Lung CT.AI is a medical device manufactured by Infervision Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-16 under approval number K240554. 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 2025-05-16. It is manufactured by Infervision Medical Technology Co., Ltd.. The 510(k) number is K240554.

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

InferRead Lung CT.AI received FDA 510(k) clearance on 2025-05-16, under approval number K240554.

What company makes InferRead Lung CT.AI?

InferRead Lung CT.AI is manufactured by Infervision Medical 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.

Other Devices by Infervision Medical Technology Co., Ltd.

K211179InferRead CT Stroke.AI

Related Devices (Code: OEB)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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