FDA 510(k)

CT/ MR 串聯及卵形組合

K 號：K250299 · 2025-05-09

決定日期2025-05-09

產品代碼JAQ

諮詢委員會RA

決定相當於

器材摘要

CT/ MR Tandem and Ovoid Set 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 2025-05-09 under 510(k) number K250299. 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 CT/ MR Tandem and Ovoid Set?

CT/ MR Tandem and Ovoid Set is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K250299.

When did CT/ MR Tandem and Ovoid Set receive FDA 510(k) clearance?

CT/ MR Tandem and Ovoid Set received FDA 510(k) clearance on 2025-05-09, under 510(k) number K250299.

Who is the listed applicant for CT/ MR Tandem and Ovoid Set?

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 CT/ MR Tandem and Ovoid Set?

The FDA product code for CT/ MR Tandem and Ovoid Set 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 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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