FDA 510(k)

Zeta经颅磁刺激导航系统

K号: K261471 · 2026-07-09

决定日期2026-07-09

产品代码QFF

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决定实质等同

器械摘要

Zeta TMS Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Zeta Surgical, Inc.. It received FDA 510(k) clearance on 2026-07-09 under 510(k) number K261471. The device is classified under product code QFF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Zeta TMS Navigation System?

Zeta TMS Navigation System is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is Zeta Surgical, Inc.. The 510(k) number is K261471.

When did Zeta TMS Navigation System receive FDA 510(k) clearance?

Zeta TMS Navigation System received FDA 510(k) clearance on 2026-07-09, under 510(k) number K261471.

Who is the listed applicant for Zeta TMS Navigation System?

The FDA 510(k) record lists Zeta Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zeta TMS Navigation System?

The FDA product code for Zeta TMS Navigation System is QFF.

列明Zeta Surgical, 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。

K253663Zeta 导航系统 K251927Zeta 导航系统（ZNS131-US）K242351Zeta头颅导航系统（ZNS131-US）K233903Zeta头颅导航系统（ZNS131-US）

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。