FDA 510(k)

uCT 780 配合 uWS-CT-Dual 能量分析

K 號：K253173 · 2026-01-20

申請人Shanghai United Imaging Healthcare Co., Ltd.

決定日期2026-01-20

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

uCT 780 with uWS-CT-Dual Energy Analysis 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 2026-01-20 under 510(k) number K253173. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the uCT 780 with uWS-CT-Dual Energy Analysis?

uCT 780 with uWS-CT-Dual Energy Analysis is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K253173.

When did uCT 780 with uWS-CT-Dual Energy Analysis receive FDA 510(k) clearance?

uCT 780 with uWS-CT-Dual Energy Analysis received FDA 510(k) clearance on 2026-01-20, under 510(k) number K253173.

Who is the listed applicant for uCT 780 with uWS-CT-Dual Energy Analysis?

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 uCT 780 with uWS-CT-Dual Energy Analysis?

The FDA product code for uCT 780 with uWS-CT-Dual Energy Analysis is JAK.

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 CX K261427uMI 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)

查看所有 85 項裝置 →

相關器械（代碼：JAK）

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。

K261125BodyTom 64 (NL4100)；OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA 觀察階段 6.0Fujifilm Corporation K253836FCT iStream 階段 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770卡迪克套件GE Medical Systems SCS K253560強化版PCCT邊界Ge Medical Systems, LLC

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。