FDA 510(k)

Axxent 電子近端放射治療系統 110 XP 1200 型號

K 號：K153570 · 2016-02-25

決定日期2016-02-25

產品代碼JAD

諮詢委員會RA

決定相當於

器材摘要

Axxent Electronic Brachytherapy System Model 110 XP 1200 is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K153570. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Axxent Electronic Brachytherapy System Model 110 XP 1200?

Axxent Electronic Brachytherapy System Model 110 XP 1200 is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Icad, Inc.. The 510(k) number is K153570.

When did Axxent Electronic Brachytherapy System Model 110 XP 1200 receive FDA 510(k) clearance?

Axxent Electronic Brachytherapy System Model 110 XP 1200 received FDA 510(k) clearance on 2016-02-25, under 510(k) number K153570.

Who is the listed applicant for Axxent Electronic Brachytherapy System Model 110 XP 1200?

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

What is the FDA product code for Axxent Electronic Brachytherapy System Model 110 XP 1200?

The FDA product code for Axxent Electronic Brachytherapy System Model 110 XP 1200 is JAD.

其他以 Icad, Inc. 為申請人之記錄

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相關器械（代碼：JAD）

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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