AI-Rad Companion 前列腺 MRI
K 號：K252608 · 2025-09-09
廣告
器材摘要
AI-Rad Companion Prostate MR is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2025-09-09 under 510(k) number K252608. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AI-Rad Companion Prostate MR?
AI-Rad Companion Prostate MR is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K252608.
When did AI-Rad Companion Prostate MR receive FDA 510(k) clearance?
AI-Rad Companion Prostate MR received FDA 510(k) clearance on 2025-09-09, under 510(k) number K252608.
Who is the listed applicant for AI-Rad Companion Prostate MR?
The FDA 510(k) record lists Siemens Healthcare GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AI-Rad Companion Prostate MR?
The FDA product code for AI-Rad Companion Prostate MR is LLZ.
相關臨床試驗
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。
其他以 Siemens Healthcare GmbH 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。
K253264我的消融導引器（VC10A）K253689syngo Dynamics (VA41F)K252548AI-Rad Companion 器官 RTK253057AI-Rad Companion 腦部 MRIK252838MAGNETOM Sola；MAGNETOM Altea；MAGNETOM Sola Fit；MAGNETOM Viato.Mobile；MAGNETOM Vida；MAGNETOM Lumina；MAGNETOM Vida Fit；MAGNETOM Flow.Elite；MAGNETOM Flow.Neo；MAGNETOM Flow.RiseK250443MAGNETOM Avanto Fit；MAGNETOM Skyra Fit；MAGNETOM Sola Fit；MAGNETOM Viato.Mobile
相關器械（代碼：LLZ）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告