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FDA 510(k)

Synapse Lung Nodule AI

K-Number: K254075 · 2026-05-27

ApplicantFujifilm Corporation
Decision Date2026-05-27
Product CodeOEB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synapse Lung Nodule AI is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K254075. 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 Synapse Lung Nodule AI?

Synapse Lung Nodule AI is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Fujifilm Corporation. The 510(k) number is K254075.

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

Synapse Lung Nodule AI received FDA 510(k) clearance on 2026-05-27, under 510(k) number K254075.

Who is the listed applicant for Synapse Lung Nodule AI?

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

What is the FDA product code for Synapse Lung Nodule AI?

The FDA product code for Synapse Lung Nodule AI is OEB.

Other records listing Fujifilm Corporation 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.

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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.

K251203AVIEW Lung Nodule CADCoreline Soft Co., Ltd.K240554InferRead Lung CT.AIInfervision Medical Technology 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

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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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