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FDA 510(k)

AVIEW Lung Nodule CAD

K-Number: K221592 · 2023-02-24

ApplicantCoreline Soft Co., Ltd.
Decision Date2023-02-24
Product CodeOEB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AVIEW Lung Nodule CAD is the device name listed in this FDA 510(k) record. The listed applicant is Coreline Soft Co., Ltd.. It received FDA 510(k) clearance on 2023-02-24 under 510(k) number K221592. 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 AVIEW Lung Nodule CAD?

AVIEW Lung Nodule CAD is a medical device that received FDA 510(k) clearance on 2023-02-24. The listed applicant is Coreline Soft Co., Ltd.. The 510(k) number is K221592.

When did AVIEW Lung Nodule CAD receive FDA 510(k) clearance?

AVIEW Lung Nodule CAD received FDA 510(k) clearance on 2023-02-24, under 510(k) number K221592.

Who is the listed applicant for AVIEW Lung Nodule CAD?

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

What is the FDA product code for AVIEW Lung Nodule CAD?

The FDA product code for AVIEW Lung Nodule CAD is OEB.

Other records listing Coreline Soft 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.

K251203AVIEW Lung Nodule CADK243689AVIEWK243696AVIEW CACK233211AVIEW CACK214036AVIEWK220408AVIEW RT ACS

View all 12 devices →

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 GmbHK221612ClearRead 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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