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FDA 510(k)

EnSite™ X EP 系統，AutoMark Index 軟體許可證（ENSITE-AMI-01）；EnSite™ X EP 系統，AutoMark Index 暫時性軟體許可證（ENSITE-D-AMI-01）

K 號：K251463 · 2025-09-04

申請人ABBOTT MEDICAL
決定日期2025-09-04
產品代碼DQK
諮詢委員會履歷
決定相當於

器材摘要

EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251463. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)?

EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K251463.

When did EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) receive FDA 510(k) clearance?

EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251463.

Who is the listed applicant for EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)?

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

What is the FDA product code for EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)?

The FDA product code for EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) is DQK.

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 ABBOTT MEDICAL 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。

K261729EnSite™ X EP 系統K262006EnSite™ X EP 系統K261631Amplatzer TorqVue 交換系統K253459OPTIS Mobile Next影像系統（1014932）；OPTIS整合型Next影像系統（1014933）；Ultreon 3.0軟體升級套件（ULTR300001）K260212EnSite™ X EP 系統K253907一次性射頻針管

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相關器械（代碼：DQK）

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。

K261729EnSite™ X EP 系統Abbott MedicalK262005Affera 整合地圖系統Medtronic, Inc.K253692AVVIGO™+ 多模態導引系統Boston ScientificK253576CorVista System® 內建 PCWP 附加功能Analytics For Life, Inc.K262006EnSite™ X EP 系統Abbott MedicalK252978ScioCardio 心電圖分析平台Synergen Technology Labs, LLC

官方來源

在 FDA 資料庫中查看 →

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