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FDA 510(k)

AVIEW Lung Nodule CAD

K-Number: K251203 · 2025-12-03

ApplicantCoreline Soft Co., Ltd.
Decision Date2025-12-03
Product CodeOEB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AVIEW Lung Nodule CAD is a medical device manufactured by Coreline Soft Co., Ltd.. It received FDA 510(k) clearance on 2025-12-03 under approval number K251203. 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 2025-12-03. It is manufactured by Coreline Soft Co., Ltd.. The 510(k) number is K251203.

When was AVIEW Lung Nodule CAD approved by the FDA?

AVIEW Lung Nodule CAD received FDA 510(k) clearance on 2025-12-03, under approval number K251203.

What company makes AVIEW Lung Nodule CAD?

AVIEW Lung Nodule CAD is manufactured by Coreline Soft Co., Ltd..

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

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

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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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