FDA 510(k)

Elekta Synergy、Elekta Harmony、Elekta Infinity、Versa HD

K 號：K210500 · 2021-06-11

決定日期2021-06-11

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Elekta Limited 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K192482艾力克塔合一 K192242Synergy 平台、Synergy、Infinity、VersaHD K182076艾力克塔合一

相關器械（代碼：IYE）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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