免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

定量总可扩展成像(QTxI)

K号: K173444 · 2018-07-23

决定日期2018-07-23
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

Quantitative Total Extensible Imaging (QTxI) is the device name listed in this FDA 510(k) record. The listed applicant is Aiq Solutions, Inc.. It received FDA 510(k) clearance on 2018-07-23 under 510(k) number K173444. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantitative Total Extensible Imaging (QTxI)?

Quantitative Total Extensible Imaging (QTxI) is a medical device that received FDA 510(k) clearance on 2018-07-23. The listed applicant is Aiq Solutions, Inc.. The 510(k) number is K173444.

When did Quantitative Total Extensible Imaging (QTxI) receive FDA 510(k) clearance?

Quantitative Total Extensible Imaging (QTxI) received FDA 510(k) clearance on 2018-07-23, under 510(k) number K173444.

Who is the listed applicant for Quantitative Total Extensible Imaging (QTxI)?

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

What is the FDA product code for Quantitative Total Extensible Imaging (QTxI)?

The FDA product code for Quantitative Total Extensible Imaging (QTxI) is LLZ.

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:LLZ)

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

在 FDA 数据库中查看 →

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。

↑