Biograph mMR 配合 syngo MR E11P-AP01 系統軟體
K 號：K200213 · 2020-05-11
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器材摘要
Biograph mMR with syngo MR E11P-AP01 system software is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-05-11 under 510(k) number K200213. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Biograph mMR with syngo MR E11P-AP01 system software?
Biograph mMR with syngo MR E11P-AP01 system software is a medical device that received FDA 510(k) clearance on 2020-05-11. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K200213.
When did Biograph mMR with syngo MR E11P-AP01 system software receive FDA 510(k) clearance?
Biograph mMR with syngo MR E11P-AP01 system software received FDA 510(k) clearance on 2020-05-11, under 510(k) number K200213.
Who is the listed applicant for Biograph mMR with syngo MR E11P-AP01 system software?
FDA 510(k) 記錄將西门子醫療解決方案美國，股份有限公司列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Biograph mMR with syngo MR E11P-AP01 system software?
The FDA product code for Biograph mMR with syngo MR E11P-AP01 system software is OUO.
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 Medical Solutions USA, 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。
相關器械（代碼：OUO）
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。
K253963Cubresa 大腦正子斷層掃描儀Cubresa, Inc.K253023BIOGRAPH 一Siemens Healthineers AGK234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K213709SIGNA 電腦斷層掃描/磁共振成像設備Ge Medical Systems, LLCK192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.
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。
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