FDA 510(k)

萊克塞爾伽馬刀Perfexion，萊克塞爾伽馬刀Icon

K 號：K173789 · 2018-03-30

決定日期2018-03-30

產品代碼IWB

諮詢委員會RA

決定相當於

器材摘要

Leksell Gamma Knife Perfexion, 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 2018-03-30 under 510(k) number K173789. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon?

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon is a medical device that received FDA 510(k) clearance on 2018-03-30. The listed applicant is Elekta Instrument AB. The 510(k) number is K173789.

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

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon received FDA 510(k) clearance on 2018-03-30, under 510(k) number K173789.

Who is the listed applicant for Leksell Gamma Knife Perfexion, 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 Perfexion, Leksell Gamma Knife Icon?

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

其他以 Elekta Instrument AB 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。

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相關器械（代碼：IWB）

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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