超聲波HepaVu
K 號：K242223 · 2024-09-20
廣告
器材摘要
SuperSonic HepaVu is the device name listed in this FDA 510(k) record. The listed applicant is Supersonic Imagine. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K242223. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SuperSonic HepaVu?
SuperSonic HepaVu is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Supersonic Imagine. The 510(k) number is K242223.
When did SuperSonic HepaVu receive FDA 510(k) clearance?
SuperSonic HepaVu received FDA 510(k) clearance on 2024-09-20, under 510(k) number K242223.
Who is the listed applicant for SuperSonic HepaVu?
The FDA 510(k) record lists Supersonic Imagine as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SuperSonic HepaVu?
The FDA product code for SuperSonic HepaVu is IYN.
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 Supersonic Imagine 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。
K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 超聲診斷系統K191007Aixplorer MACH 30, Aixplorer MACH 20 超聲診斷系統K180572AIXPLORER MACH 超聲診斷系統 Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10K173021Aixplorer & Aixplorer Ultimate 超聲診斷系統
相關器械（代碼：IYN）
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。
K263182EVO X30 診斷超音波系統；EVO X20 診斷超音波系統；EVO X10 診斷超音波系統；EVO XP30 診斷超音波系統；EVO XP20 診斷超音波系統；EVO XP10 診斷超音波系統；EVO XC30 診斷超音波系統；EVO XC20 診斷超音波系統；EVO XC10 診斷超音波系統Samsung Medison Co., Ltd.K262548EPIQ 吸引系列診斷超聲波系統；Affiniti 系列診斷超聲波系統Philips Ultrasound, LLCK261313Vivid 探索者/Vivid 高級/Vivid 焦點GE Medical Systems Ultrasound and Primary Care DiagnosticsK254027數位顏色多普勒超聲系統（Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90）Sonoscape Medical Corp.K261668場地 走GE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Alturion Series 體診超聲系統Philips Ultrasound, 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。
廣告