FDA 510(k)

Leksell Vantage 立体定向系统

K号: K171123 · 2017-09-15

决定日期2017-09-15

产品代码HAW

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决定实质等同

器械摘要

Leksell Vantage Stereotactic System 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 2017-09-15 under 510(k) number K171123. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Leksell Vantage Stereotactic System?

Leksell Vantage Stereotactic System is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Elekta Instrument AB. The 510(k) number is K171123.

When did Leksell Vantage Stereotactic System receive FDA 510(k) clearance?

Leksell Vantage Stereotactic System received FDA 510(k) clearance on 2017-09-15, under 510(k) number K171123.

Who is the listed applicant for Leksell Vantage Stereotactic System?

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 Vantage Stereotactic System?

The FDA product code for Leksell Vantage Stereotactic System is HAW.

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。

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