FDA 510(k)

AI-Rad Companion (心血管)

K 號：K222360 · 2023-04-06

決定日期2023-04-06

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

AI-Rad Companion (Cardiovascular) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions U.S.A.. It received FDA 510(k) clearance on 2023-04-06 under 510(k) number K222360. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AI-Rad Companion (Cardiovascular)?

AI-Rad Companion (Cardiovascular) is a medical device that received FDA 510(k) clearance on 2023-04-06. The listed applicant is Siemens Medical Solutions U.S.A.. The 510(k) number is K222360.

When did AI-Rad Companion (Cardiovascular) receive FDA 510(k) clearance?

AI-Rad Companion (Cardiovascular) received FDA 510(k) clearance on 2023-04-06, under 510(k) number K222360.

Who is the listed applicant for AI-Rad Companion (Cardiovascular)?

The FDA 510(k) record lists Siemens Medical Solutions U.S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI-Rad Companion (Cardiovascular)?

The FDA product code for AI-Rad Companion (Cardiovascular) is JAK.

其他以 Siemens Medical Solutions U.S.A. 為申請人之記錄

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相關器械（代碼：JAK）

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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