FDA 510(k)

EFAI 智能心胸比（iCTR）评估系统

K号: K212624 · 2022-04-04

决定日期2022-04-04

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is the device name listed in this FDA 510(k) record. The listed applicant is Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2022-04-04 under 510(k) number K212624. 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 EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System?

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is a medical device that received FDA 510(k) clearance on 2022-04-04. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K212624.

When did EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System receive FDA 510(k) clearance?

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System received FDA 510(k) clearance on 2022-04-04, under 510(k) number K212624.

Who is the listed applicant for EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System?

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

What is the FDA product code for EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System?

The FDA product code for EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is QIH.

列明Ever Fortune.Ai, 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。

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