FDA 510(k)

Eve病患位置系統

K 號：K231612 · 2024-05-07

決定日期2024-05-07

產品代碼JAI

諮詢委員會RA

決定相當於

器材摘要

Eve Patient Positioner System is the device name listed in this FDA 510(k) record. The listed applicant is Leo Cancer Care. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K231612. The device is classified under product code JAI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Eve Patient Positioner System?

Eve Patient Positioner System is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Leo Cancer Care. The 510(k) number is K231612.

When did Eve Patient Positioner System receive FDA 510(k) clearance?

Eve Patient Positioner System received FDA 510(k) clearance on 2024-05-07, under 510(k) number K231612.

Who is the listed applicant for Eve Patient Positioner System?

The FDA 510(k) record lists Leo Cancer Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eve Patient Positioner System?

The FDA product code for Eve Patient Positioner System is JAI.

其他以 Leo Cancer Care 為申請人之記錄

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K250970馬麗

相關器械（代碼：JAI）

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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官方來源

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