FDA 510(k)

導向阿魯斯應用器組

K 號：K252884 · 2025-11-19

決定日期2025-11-19

產品代碼JAQ

諮詢委員會RA

決定相當於

器材摘要

Guided Aarhus Applicator Set is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems. It received FDA 510(k) clearance on 2025-11-19 under 510(k) number K252884. 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 Guided Aarhus Applicator Set?

Guided Aarhus Applicator Set is a medical device that received FDA 510(k) clearance on 2025-11-19. The listed applicant is Varian Medical Systems. The 510(k) number is K252884.

When did Guided Aarhus Applicator Set receive FDA 510(k) clearance?

Guided Aarhus Applicator Set received FDA 510(k) clearance on 2025-11-19, under 510(k) number K252884.

Who is the listed applicant for Guided Aarhus Applicator Set?

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

What is the FDA product code for Guided Aarhus Applicator Set?

The FDA product code for Guided Aarhus Applicator Set is JAQ.

其他以 Varian Medical Systems 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。

K261306AI Contouring (VA10A)K252717MAASTRO 直腸施藥器組 K250099Mobius3D (4.1)K250289內腔/間質系統 K242378Eclipse治療計劃系統（18.1）K242961內腔應用器組

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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.K250299CT/ MR 串聯及卵形組合Varian Medical Systems, Inc.K250289內腔/間質系統Varian Medical Systems K243939钛材柔軟幾何形態FSD應用器組合（GM11013400）Varian Medical Systems, Inc.

官方來源

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