FDA 510(k)

內腔/間質系統

K 號：K250289 · 2025-04-25

決定日期2025-04-25

產品代碼JAQ

諮詢委員會RA

決定相當於

器材摘要

Intracavitary/Interstitial System 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 2025-04-25 under 510(k) number K250289. 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 Intracavitary/Interstitial System?

Intracavitary/Interstitial System is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Varian Medical Systems. The 510(k) number is K250289.

When did Intracavitary/Interstitial System receive FDA 510(k) clearance?

Intracavitary/Interstitial System received FDA 510(k) clearance on 2025-04-25, under 510(k) number K250289.

Who is the listed applicant for Intracavitary/Interstitial System?

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 Intracavitary/Interstitial System?

The FDA product code for Intracavitary/Interstitial System 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 K252884導向阿魯斯應用器組 K250099Mobius3D (4.1)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.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.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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