FDA 510(k)

AVIEW 肺结节 CAD

K号: K251203 · 2025-12-03

决定日期2025-12-03

产品代码OEB

咨询委员会RA

决定实质等同

器械摘要

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 2025-12-03 under 510(k) number K251203. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Coreline Soft Co., Ltd.. The 510(k) number is K251203.

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

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

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.

列明Coreline Soft Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K243689AVIEW K243696AVIEW CAC K233211AVIEW CAC K221592AVIEW 肺结节 CAD K214036AVIEW K220408AVIEW RT ACS

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。