uMR 680
K 號：K243397 · 2025-07-16
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器材摘要
uMR 680 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 2025-07-16 under 510(k) number K243397. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the uMR 680?
uMR 680 is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K243397.
When did uMR 680 receive FDA 510(k) clearance?
uMR 680 received FDA 510(k) clearance on 2025-07-16, under 510(k) number K243397.
Who is the listed applicant for uMR 680?
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 uMR 680?
The FDA product code for uMR 680 is LNH.
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：LNH）
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
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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