FDA 510(k)

互鎖環形小範圍擴散器，Elekta整合式

K 號：K161984 · 2016-09-27

決定日期2016-09-27

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

Interlocked Circular Small Field Collimators, Elekta Integrated is the device name listed in this FDA 510(k) record. The listed applicant is Aktina Medical Corporation. It received FDA 510(k) clearance on 2016-09-27 under 510(k) number K161984. 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 Interlocked Circular Small Field Collimators, Elekta Integrated?

Interlocked Circular Small Field Collimators, Elekta Integrated is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is Aktina Medical Corporation. The 510(k) number is K161984.

When did Interlocked Circular Small Field Collimators, Elekta Integrated receive FDA 510(k) clearance?

Interlocked Circular Small Field Collimators, Elekta Integrated received FDA 510(k) clearance on 2016-09-27, under 510(k) number K161984.

Who is the listed applicant for Interlocked Circular Small Field Collimators, Elekta Integrated?

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

What is the FDA product code for Interlocked Circular Small Field Collimators, Elekta Integrated?

The FDA product code for Interlocked Circular Small Field Collimators, Elekta Integrated is IYE.

其他以 Aktina Medical Corporation 為申請人之記錄

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K192102熱塑性口罩

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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