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FDA 510(k)

syngo.CT Lung CAD

K-Number: K203258 · 2021-03-31

ApplicantSiemens Healthcare GmbH
Decision Date2021-03-31
Product CodeOEB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.CT Lung CAD is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2021-03-31 under 510(k) number K203258. 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 syngo.CT Lung CAD?

syngo.CT Lung CAD is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K203258.

When did syngo.CT Lung CAD receive FDA 510(k) clearance?

syngo.CT Lung CAD received FDA 510(k) clearance on 2021-03-31, under 510(k) number K203258.

Who is the listed applicant for syngo.CT Lung CAD?

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

What is the FDA product code for syngo.CT Lung CAD?

The FDA product code for syngo.CT Lung CAD is OEB.

Other records listing Siemens Healthcare GmbH 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.

K253264myAblation Guide (VC10A)K253689syngo Dynamics (VA41F)K252548AI-Rad Companion Organs RTK253057AI-Rad Companion Brain MRK252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseK252608AI-Rad Companion Prostate MR

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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.

K254075Synapse Lung Nodule AIFujifilm CorporationK251203AVIEW 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.

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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