FDA 510(k)

Leksell Gamma Knife Icon

K号: K160440 · 2016-04-20

决定日期2016-04-20

产品代码IWB

咨询委员会RA

决定实质等同

器械摘要

Leksell Gamma Knife Icon is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Instrument AB. It received FDA 510(k) clearance on 2016-04-20 under 510(k) number K160440. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Leksell Gamma Knife Icon?

Leksell Gamma Knife Icon is a medical device that received FDA 510(k) clearance on 2016-04-20. The listed applicant is Elekta Instrument AB. The 510(k) number is K160440.

When did Leksell Gamma Knife Icon receive FDA 510(k) clearance?

Leksell Gamma Knife Icon received FDA 510(k) clearance on 2016-04-20, under 510(k) number K160440.

Who is the listed applicant for Leksell Gamma Knife Icon?

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

What is the FDA product code for Leksell Gamma Knife Icon?

The FDA product code for Leksell Gamma Knife Icon is IWB.

列明Elekta Instrument AB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。

K190887Leksell Vantage 立体定向系统 K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon K173791Leksell GammaPlan K171123Leksell Vantage 立体定向系统 K152558Leksell 立体定向系统，注射/吸引针套装

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。