FDA 510(k)

Raycast高精度肺板解决方案

K号: K162862 · 2016-11-09

决定日期2016-11-09

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Raycast High Precision Lung Board Solution is the device name listed in this FDA 510(k) record. The listed applicant is Orfit Industries NV. It received FDA 510(k) clearance on 2016-11-09 under 510(k) number K162862. 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 Raycast High Precision Lung Board Solution?

Raycast High Precision Lung Board Solution is a medical device that received FDA 510(k) clearance on 2016-11-09. The listed applicant is Orfit Industries NV. The 510(k) number is K162862.

When did Raycast High Precision Lung Board Solution receive FDA 510(k) clearance?

Raycast High Precision Lung Board Solution received FDA 510(k) clearance on 2016-11-09, under 510(k) number K162862.

Who is the listed applicant for Raycast High Precision Lung Board Solution?

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

What is the FDA product code for Raycast High Precision Lung Board Solution?

The FDA product code for Raycast High Precision Lung Board Solution is IYE.

列明Orfit Industries NV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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