FDA 510(k)

Encompass SRS Headframe ; Encompass MR SRS Headframe

K号: K182189 · 2018-10-04

申请人Qfix

决定日期2018-10-04

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Encompass SRS Headframe ; Encompass MR SRS Headframe is the device name listed in this FDA 510(k) record. The listed applicant is Qfix. It received FDA 510(k) clearance on 2018-10-04 under 510(k) number K182189. 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 Encompass SRS Headframe ; Encompass MR SRS Headframe?

Encompass SRS Headframe ; Encompass MR SRS Headframe is a medical device that received FDA 510(k) clearance on 2018-10-04. The listed applicant is Qfix. The 510(k) number is K182189.

When did Encompass SRS Headframe ; Encompass MR SRS Headframe receive FDA 510(k) clearance?

Encompass SRS Headframe ; Encompass MR SRS Headframe received FDA 510(k) clearance on 2018-10-04, under 510(k) number K182189.

Who is the listed applicant for Encompass SRS Headframe ; Encompass MR SRS Headframe?

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 Encompass SRS Headframe ; Encompass MR SRS Headframe?

The FDA product code for Encompass SRS Headframe ; Encompass MR SRS Headframe 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。

K230312Iris AirShuttle™K193243Alta 多用途设备 K190668Encompass 15 Channel Head Coil, 3T 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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