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FDA 510(k)

Mobius3D (4.1)

K 號:K250099 · 2025-05-16

決定日期2025-05-16
產品代碼IYE
諮詢委員會RA
決定相當於

器材摘要

Mobius3D (4.1) 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 2025-05-16 under 510(k) number K250099. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mobius3D (4.1)?

Mobius3D (4.1) is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Varian Medical Systems. The 510(k) number is K250099.

When did Mobius3D (4.1) receive FDA 510(k) clearance?

Mobius3D (4.1) received FDA 510(k) clearance on 2025-05-16, under 510(k) number K250099.

Who is the listed applicant for Mobius3D (4.1)?

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 Mobius3D (4.1)?

The FDA product code for Mobius3D (4.1) is IYE.

相關臨床試驗

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其他以 Varian Medical Systems 為申請人之記錄

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相關器械(代碼:IYE)

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。

官方來源

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