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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 the device name listed in this FDA 510(k) record. The listed applicant is Infervision Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) 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. The listed applicant is Infervision Medical Technology Co., Ltd.. The 510(k) number is K240554.

When did InferRead Lung CT.AI receive FDA 510(k) clearance?

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

Who is the listed applicant for InferRead Lung CT.AI?

The FDA 510(k) record lists Infervision Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Infervision Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211179InferRead CT Stroke.AI

Related Devices (Code: OEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254075Synapse Lung Nodule AIFujifilm CorporationK251203AVIEW Lung Nodule CADCoreline Soft Co., Ltd.K242919V5med Lung AIV5med, Inc.K231157syngo.CT Lung CAD (Version VD30)Siemens Healthcare GmbHK221592AVIEW Lung Nodule CADCoreline Soft Co., Ltd.K221612ClearRead CTRiverain Technologies, Inc.

Official Source

View on FDA Database →

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

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