FDA 510(k)

Qfix® 腹部/胸部运动控制系统，Qfix® SBRT 解决方案和附件

K号: K171133 · 2017-07-11

申请人Qfix

决定日期2017-07-11

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Qfix. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K171133. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories?

Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Qfix. The 510(k) number is K171133.

When did Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories receive FDA 510(k) clearance?

Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories received FDA 510(k) clearance on 2017-07-11, under 510(k) number K171133.

Who is the listed applicant for Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories?

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

What is the FDA product code for Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories?

The FDA product code for Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories is IYE.

列明Qfix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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官方来源

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