FDA 510(k)

Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)

K号: K251792 · 2025-11-06

决定日期2025-11-06

产品代码DXX

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

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.

常见问题

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)记录中列出Stereotaxis, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

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.

列明Stereotaxis, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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