uMI Panvivo (uMI Panvivo)；uMI Panvivo (uMI Panvivo S)
K 號：K251839 · 2025-07-17
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器材摘要
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) 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 2025-07-17 under 510(k) number K251839. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)?
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) is a medical device that received FDA 510(k) clearance on 2025-07-17. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K251839.
When did uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) receive FDA 510(k) clearance?
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) received FDA 510(k) clearance on 2025-07-17, under 510(k) number K251839.
Who is the listed applicant for uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)?
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 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)?
The FDA product code for uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) is KPS.
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 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：KPS）
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。
K261305MICSI-PETMicrostructure Imaging, Inc.K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.K261315Symbia Pro.specta Q3 (11364751)；Symbia Pro.specta X3 (11364752)；Symbia Pro.specta X7 (11364753)；Symbia Pro.specta VA40 系列Siemens Medical Solutions USA, Inc.K260524uMI Panvivo (uMI Panvivo LS)；uMI Panvivo (uMI Panvivo)；uMI Panvivo (uMI Panvivo S)；uMI Panvivo (uMI Panvivo EX)；uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K253564uMI Panvivo (uMI Panvivo)；uMI Panvivo (uMI Panvivo S)；uMI Panvivo (uMI Panvivo EX)；uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K254001VERITON CT 300系列數位SPECT/CT系統（VERITON CT 316/364）；VERITON CT 400系列數位SPECT/CT系統（VERITON CT 416/464）Spectrum Dynamics Medical, 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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