FDA 510(k)

Stereotaxis GenesisX RMN 配置 Navigant™工作站（NWS）

K 號：K251792 · 2025-11-06

決定日期2025-11-06

產品代碼DXX

諮詢委員會履歷

決定相當於

器材摘要

Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K251792. The device is classified under product code DXX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)?

Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K251792.

When did Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) receive FDA 510(k) clearance?

Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) received FDA 510(k) clearance on 2025-11-06, under 510(k) number K251792.

Who is the listed applicant for Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)?

FDA 510(k) 記錄將Stereotaxis, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)?

The FDA product code for Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) is DXX.

其他以 Stereotaxis, 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。

K262744GenesisX RMN K253473同步 K250590MAGiC Sweep™ EP描記電極导管 K193147Stereotaxis Genesis RMN 配置 Navigant 工作站 (NWS) 及 Cardiodrive 系統 K192775Niobe® 磁性導航系統 (MNS) 配備 Navigant 工作站 (NWS) 及 Cardiodri K183027可調向心導管控制系統

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相關器械（代碼：DXX）

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。

K262744GenesisX RMNStereotaxis, Inc.K243789LIBERTY內血管機器人系統（LIBERTYOS）Microbot Medical , Ltd.K221464CorPath GRX 系統Corindus, Inc.K202275CorPath GRX 系統Corindus, Inc.K180517CorPath GRX 系統Corindus, Inc.K173806CorPath GRX 系統Corindus, Inc.

官方來源

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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。