FDA 510(k)

钛材柔軟幾何形態FSD應用器組合（GM11013400）

K 號：K243939 · 2025-03-03

決定日期2025-03-03

產品代碼JAQ

諮詢委員會RA

決定相當於

器材摘要

Titanium Flexible Geometry FSD Applicator Set (GM11013400) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-03-03 under 510(k) number K243939. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Titanium Flexible Geometry FSD Applicator Set (GM11013400)?

Titanium Flexible Geometry FSD Applicator Set (GM11013400) is a medical device that received FDA 510(k) clearance on 2025-03-03. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K243939.

When did Titanium Flexible Geometry FSD Applicator Set (GM11013400) receive FDA 510(k) clearance?

Titanium Flexible Geometry FSD Applicator Set (GM11013400) received FDA 510(k) clearance on 2025-03-03, under 510(k) number K243939.

Who is the listed applicant for Titanium Flexible Geometry FSD Applicator Set (GM11013400)?

FDA 510(k) 記錄將 Varian Medical Systems, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Titanium Flexible Geometry FSD Applicator Set (GM11013400)?

The FDA product code for Titanium Flexible Geometry FSD Applicator Set (GM11013400) is JAQ.

其他以 Varian Medical Systems, Inc. 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：JAQ）

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。

K262383LumenCare 銀河Nucletron B.V.K252717MAASTRO 直腸施藥器組Varian Medical Systems K251037直腸施藥器Nucletron B.V.K252884導向阿魯斯應用器組Varian Medical Systems K250299CT/ MR 串聯及卵形組合Varian Medical Systems, Inc.K250289內腔/間質系統Varian Medical Systems

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。