免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Symbia Pro.specta Q3 (11364751)；Symbia Pro.specta X3 (11364752)；Symbia Pro.specta X7 (11364753)；Symbia Pro.specta VA40 系列

K 號：K261315 · 2026-05-21

申請人Siemens Medical Solutions USA, Inc.
決定日期2026-05-21
產品代碼KPS
諮詢委員會RA
決定相當於

器材摘要

Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family 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 2026-05-21 under 510(k) number K261315. 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 Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family?

Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K261315.

When did Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family receive FDA 510(k) clearance?

Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family received FDA 510(k) clearance on 2026-05-21, under 510(k) number K261315.

Who is the listed applicant for Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family?

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 Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family?

The FDA product code for Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family 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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K260055syngo.CT 脑量化K261696ACUNAV Luxera 4D ICE 絲膜燒灼器K260488MULTIX 震擊；MULTIX 震擊 CK253786syngo.CT 心臟駕駛艙K253678MAMMOMAT B.閃耀 (11372950)K260844ACUSON Sequoia 診斷超聲系統;ACUSON Sequoia Select 診斷超聲系統;ACUSON Origin 診斷超聲系統;ACUSON Origin ICE 診斷超聲系統

查看所有 254 項裝置 →

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.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.K253844AnyScan 3.0 NM 扫描器系列Mediso Medical Imaging Systems, 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。

↑