FDA 510(k)

Zeta 頭部導航系統 (ZNS131-US)

K 號：K233903 · 2024-01-10

決定日期2024-01-10

產品代碼HAW

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Zeta Cranial Navigation System (ZNS131-US) 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 2024-01-10 under 510(k) number K233903. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zeta Cranial Navigation System (ZNS131-US)?

Zeta Cranial Navigation System (ZNS131-US) is a medical device that received FDA 510(k) clearance on 2024-01-10. The listed applicant is Zeta Surgical, Inc.. The 510(k) number is K233903.

When did Zeta Cranial Navigation System (ZNS131-US) receive FDA 510(k) clearance?

Zeta Cranial Navigation System (ZNS131-US) received FDA 510(k) clearance on 2024-01-10, under 510(k) number K233903.

Who is the listed applicant for Zeta Cranial Navigation System (ZNS131-US)?

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 Cranial Navigation System (ZNS131-US)?

The FDA product code for Zeta Cranial Navigation System (ZNS131-US) is HAW.

其他以 Zeta Surgical, 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。

K261471Zeta TMS導航系統 K253663Zeta導航系統 K251927Zeta導航系統（ZNS131-US）K242351Zeta 頭部導航系統 (ZNS131-US)

相關器械（代碼：HAW）

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。

K253856Geniant Cranial（導航神經外科定位機器人）Koh Young Technology, Inc.K261932萊克塞爾® Vantage 積極定位系統Elekta Solutions AB K253663Zeta導航系統Zeta Surgical, Inc.K253379Stealth AXiS 頭部臨床應用Medtronic Navigation, Inc.K231897神經對齊軟體Medivis, Inc.K251317SOLOPASS 2.0 系統Intravent Medical Partners

官方來源

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