FDA 510(k)

V5med Lung AI

K-Number: K242919 · 2025-03-27

Decision Date2025-03-27

Product CodeOEB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

V5med Lung AI is the device name listed in this FDA 510(k) record. The listed applicant is V5med, Inc.. It received FDA 510(k) clearance on 2025-03-27 under 510(k) number K242919. 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 V5med Lung AI?

V5med Lung AI is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is V5med, Inc.. The 510(k) number is K242919.

When did V5med Lung AI receive FDA 510(k) clearance?

V5med Lung AI received FDA 510(k) clearance on 2025-03-27, under 510(k) number K242919.

Who is the listed applicant for V5med Lung AI?

The FDA 510(k) record lists V5med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V5med Lung AI?

The FDA product code for V5med Lung AI is OEB.

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 Corporation K251203AVIEW Lung Nodule CADCoreline Soft Co., Ltd.K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.K231157syngo.CT Lung CAD (Version VD30)Siemens Healthcare GmbH K221592AVIEW Lung Nodule CADCoreline Soft Co., Ltd.K221612ClearRead CTRiverain Technologies, Inc.

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.