FDA 510(k)

Iris AirShuttle™

K号: K230312 · 2023-03-31

申请人Qfix

决定日期2023-03-31

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Iris AirShuttle™ is the device name listed in this FDA 510(k) record. The listed applicant is Qfix. It received FDA 510(k) clearance on 2023-03-31 under 510(k) number K230312. 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 Iris AirShuttle™?

Iris AirShuttle™ is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is Qfix. The 510(k) number is K230312.

When did Iris AirShuttle™ receive FDA 510(k) clearance?

Iris AirShuttle™ received FDA 510(k) clearance on 2023-03-31, under 510(k) number K230312.

Who is the listed applicant for Iris AirShuttle™?

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 Iris AirShuttle™?

The FDA product code for Iris AirShuttle™ 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。

K193243Alta 多用途设备 K190668Encompass 15 Channel Head Coil, 3T K182189Encompass SRS Headframe ; Encompass MR SRS Headframe K171133Qfix® 腹部/胸部运动控制系统，Qfix® SBRT 解决方案和附件 K160627Symphony 患者转运系统，Symphony 患者手推车，Symphony 标准转移表面，Symphony 肖像（头部/颈部）转移表面，Symphony 近距离治疗解决方案

官方来源

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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。