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)

Aquilion Lightning, TSX-035A/4 和 /5, V7.0

K 號：K153263 · 2016-04-01

申請人Toshibamedical Systems Corporation
決定日期2016-04-01
產品代碼JAK
諮詢委員會RA
決定相當於

器材摘要

Aquilion Lightning, TSX-035A/4 and /5, V7.0 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-04-01 under 510(k) number K153263. 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 Aquilion Lightning, TSX-035A/4 and /5, V7.0?

Aquilion Lightning, TSX-035A/4 and /5, V7.0 is a medical device that received FDA 510(k) clearance on 2016-04-01. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K153263.

When did Aquilion Lightning, TSX-035A/4 and /5, V7.0 receive FDA 510(k) clearance?

Aquilion Lightning, TSX-035A/4 and /5, V7.0 received FDA 510(k) clearance on 2016-04-01, under 510(k) number K153263.

Who is the listed applicant for Aquilion Lightning, TSX-035A/4 and /5, V7.0?

The FDA 510(k) record lists Toshibamedical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aquilion Lightning, TSX-035A/4 and /5, V7.0?

The FDA product code for Aquilion Lightning, TSX-035A/4 and /5, V7.0 is JAK.

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 Toshibamedical Systems Corporation 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。

K173962Viamo c100 TUS-VC100 診斷超音波系統K173468Aquilion Precision (TSX-304A/2) V8.6 與 FIRST 3.0K173088Vitrea 軟體 東芝 包裝 VSTP-001AK173382Vantage Galan 3T, V4.6K173090Aplio i900/i800/i700/i600 診斷超音波系統，V2.4K172863Infinix-i, INFX-8000V, V7.0

查看所有 27 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 CorporationK253836FCT iStream 階段 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770卡迪克套件GE Medical Systems SCSK253560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。

↑