FDA 510(k)

AVIEW CAC

K号: K233211 · 2024-03-29

决定日期2024-03-29

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

AVIEW CAC 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 2024-03-29 under 510(k) number K233211. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AVIEW CAC?

AVIEW CAC is a medical device that received FDA 510(k) clearance on 2024-03-29. The listed applicant is Coreline Soft Co., Ltd.. The 510(k) number is K233211.

When did AVIEW CAC receive FDA 510(k) clearance?

AVIEW CAC received FDA 510(k) clearance on 2024-03-29, under 510(k) number K233211.

Who is the listed applicant for AVIEW CAC?

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 CAC?

The FDA product code for AVIEW CAC is QIH.

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。

K251203AVIEW 肺结节 CAD K243689AVIEW K243696AVIEW CAC K221592AVIEW 肺结节 CAD K214036AVIEW K220408AVIEW RT ACS

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官方来源

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