FDA 510(k)

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD

K号: K210500 · 2021-06-11

决定日期2021-06-11

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Limited. It received FDA 510(k) clearance on 2021-06-11 under 510(k) number K210500. 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 Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD?

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Elekta Limited. The 510(k) number is K210500.

When did Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD receive FDA 510(k) clearance?

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD received FDA 510(k) clearance on 2021-06-11, under 510(k) number K210500.

Who is the listed applicant for Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD?

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

What is the FDA product code for Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD?

The FDA product code for Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD is IYE.

列明Elekta Limited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。

K192482Elekta Unity K192242Synergy 平台，Synergy，Infinity，VersaHD K182076Elekta Unity

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。