FDA 510(k)

エレクタ・シンエラ、エレクタ・ハーモニー、エレクタ・インフィニティ、ベルサ・HD

K番号: K210500 · 2021-06-11

決定日2021-06-11

製品コードIYE

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてElekta Limitedを記載するその他の記録

K192482エレクタ・ユニティ K192242シンエジー・プラットフォーム、シンエジー、インフィニティ、ベルシャHD K182076エレクタ・ユニティ

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