uPMR 790
K 號：K234154 · 2024-05-24
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器材摘要
uPMR 790 is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K234154. 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 uPMR 790?
uPMR 790 is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K234154.
When did uPMR 790 receive FDA 510(k) clearance?
uPMR 790 received FDA 510(k) clearance on 2024-05-24, under 510(k) number K234154.
Who is the listed applicant for uPMR 790?
FDA 510(k) 記錄將上海聯合醫療儀器有限公司列為申請人。這並不單獨確立設備製造商的身份。
What is the FDA product code for uPMR 790?
The FDA product code for uPMR 790 is OUO.
其他以 Shanghai United Imaging Healthcare Co., Ltd. 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。
K253726uAngio AVIVA CXK261427uMI Panvivo (uMI Panvivo M)K260113uMR 阿斯特拉K253077uOmnispace.MR醫療設備規範文本翻譯：
uOmnispace.MR醫療設備K260524uMI Panvivo (uMI Panvivo LS)；uMI Panvivo (uMI Panvivo)；uMI Panvivo (uMI Panvivo S)；uMI Panvivo (uMI Panvivo EX)；uMI Panvivo (uMI Panvivo ES)K253564uMI Panvivo (uMI Panvivo)；uMI Panvivo (uMI Panvivo S)；uMI Panvivo (uMI Panvivo EX)；uMI Panvivo (uMI Panvivo ES)
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 AGK222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K213709SIGNA 電腦斷層掃描/磁共振成像設備Ge Medical Systems, LLCK200213Biograph mMR 配合 syngo MR E11P-AP01 系統軟體Siemens Medical Solutions USA, Inc.K192672uPMR 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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