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FDA 510(k)

LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY

K-Number: K033374 · 2003-11-06

ApplicantSiemens AG Medical Solutions
Decision Date2003-11-06
Product CodeOEB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY is the device name listed in this FDA 510(k) record. The listed applicant is Siemens AG Medical Solutions. It received FDA 510(k) clearance on 2003-11-06 under 510(k) number K033374. 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 LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY?

LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY is a medical device that received FDA 510(k) clearance on 2003-11-06. The listed applicant is Siemens AG Medical Solutions. The 510(k) number is K033374.

When did LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY receive FDA 510(k) clearance?

LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY received FDA 510(k) clearance on 2003-11-06, under 510(k) number K033374.

Who is the listed applicant for LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY?

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

What is the FDA product code for LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY?

The FDA product code for LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY is OEB.

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Other records listing Siemens AG Medical Solutions 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.

K123920SYNGO.VIAK120331SYNGO CT DYNAMIC ANGIOK111079SYNGO.VIA WEB VIEWERK101666SYNGO. PLAZA VA20AK100637SYNGO.CT CORONARY ANALYSISK093612SYNGO.PLAZA

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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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