FDA 510(k)

Swift 系統

K 號：K181941 · 2018-10-18

決定日期2018-10-18

產品代碼NEY

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Swift System is the device name listed in this FDA 510(k) record. The listed applicant is Emblation , Ltd.. It received FDA 510(k) clearance on 2018-10-18 under 510(k) number K181941. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Swift System?

Swift System is a medical device that received FDA 510(k) clearance on 2018-10-18. The listed applicant is Emblation , Ltd.. The 510(k) number is K181941.

When did Swift System receive FDA 510(k) clearance?

Swift System received FDA 510(k) clearance on 2018-10-18, under 510(k) number K181941.

Who is the listed applicant for Swift System?

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

What is the FDA product code for Swift System?

The FDA product code for Swift System is NEY.

其他以 Emblation , Ltd. 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。

K222388swiftPro系統

相關器械（代碼：NEY）

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。

K252632微波消融設備Nanjing Dewen Medical Technology Co., Ltd.K253771可棄式微波消融天線 (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)Nanjing Devin Medical Technology Co., Ltd.K250718swiftPro系統 (SWF-SPS)；Swift系統 (SWF-SYS)Emblation Limited K241827微波消融發生器（KY-2000A、KY-2100A）Canyon Medical, Inc.K241825微波消融天線Canyon Medical, Inc.K240480IntelliBlate 麻醉微波消融系統控制台（IB-CON）；IntelliBlate 麻醉微波消融系統移動車（IB-CART）；IntelliBlate Ximitry 探頭組裝，13G x 15cm（IB-XPA-1315）；IntelliBlate Ximitry 探頭組裝，13G x 20cm（IB-XPA-1320）；IntelliBlate Ximitry 探頭組裝，13G x 27cm（IB-XPA-1327）Varian Medical Systems, Inc.

官方來源

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