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FDA 510(k)

Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/纖維 7/纖維 6/纖維 5 超聲波診斷系統

K 號：K251601 · 2025-12-03

申請人Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
決定日期2025-12-03
產品代碼IYN
諮詢委員會RA
決定相當於

器材摘要

Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-12-03 under 510(k) number K251601. 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 Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem?

Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem is a medical device that received FDA 510(k) clearance on 2025-12-03. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K251601.

When did Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem receive FDA 510(k) clearance?

Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem received FDA 510(k) clearance on 2025-12-03, under 510(k) number K251601.

Who is the listed applicant for Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem?

The FDA product code for Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem is IYN.

相關臨床試驗

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其他以 Shenzhen Mindray Bio-Medical Electronics 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。

K253330A5 麻醉系統 (A5)；A7 麻醉系統 (A7)K260098ePM系列病人監護儀（ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC）K260846診斷超音波系統（MU9）；診斷超音波系統（MU9S）；診斷超音波系統（MU9T）；診斷超音波系統（MU9 Exp）；診斷超音波系統（MU9 Pro）；診斷超音波系統（MU9 Super）；診斷超音波系統（MU9P）；診斷超音波系統（MU9A）；診斷超音波系統（MU7）；診斷超音波系統（MU7S）；診斷超音波系統（MU7T）；診斷超音波系統（MU7 Exp）；診斷超音波系統（MU7 Pro）；診斷超音波系統K253170uMEC 60/ uMEC 70/ uMEC 80/ uMEC 100/ uMEC 120/ uMEC 150 病患監護儀K252182SV70呼吸器（SV70）K253049Resona A10S、Resona A20 Pro、Resona A20T、Resona A20S、Resona A20W、Resona A20、Resona A20 Exp、Resona A20 Premium、Resona A20 Elite、Resona A20 Plus、Resona A Elite、Resona A MV、Eagus A20W、Eagus A20 診斷超音波系統

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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

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