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FDA 510(k)

AIMI-Triage CXR PTX

K号: K193300 · 2020-04-08

决定日期2020-04-08
产品代码QFM
咨询委员会RA
决定实质等同

器械摘要

AIMI-Triage CXR PTX is the device name listed in this FDA 510(k) record. The listed applicant is Radlogics, Inc.. It received FDA 510(k) clearance on 2020-04-08 under 510(k) number K193300. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AIMI-Triage CXR PTX?

AIMI-Triage CXR PTX is a medical device that received FDA 510(k) clearance on 2020-04-08. The listed applicant is Radlogics, Inc.. The 510(k) number is K193300.

When did AIMI-Triage CXR PTX receive FDA 510(k) clearance?

AIMI-Triage CXR PTX received FDA 510(k) clearance on 2020-04-08, under 510(k) number K193300.

Who is the listed applicant for AIMI-Triage CXR PTX?

The FDA 510(k) record lists Radlogics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIMI-Triage CXR PTX?

The FDA product code for AIMI-Triage CXR PTX is QFM.

相关临床试验

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。

相关器械(代码:QFM)

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。

官方来源

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