FDA 510(k)

X-Guide® 外科導航系統

K 號：K211701 · 2022-02-01

決定日期2022-02-01

產品代碼QRY

諮詢委員會DE

決定相當於

器材摘要

X-Guide® Surgical Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is X-Nav Technologies, LLC. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K211701. The device is classified under product code QRY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the X-Guide® Surgical Navigation System?

X-Guide® Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is X-Nav Technologies, LLC. The 510(k) number is K211701.

When did X-Guide® Surgical Navigation System receive FDA 510(k) clearance?

X-Guide® Surgical Navigation System received FDA 510(k) clearance on 2022-02-01, under 510(k) number K211701.

Who is the listed applicant for X-Guide® Surgical Navigation System?

FDA 510(k) 記錄將 X-Nav Technologies, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for X-Guide® Surgical Navigation System?

The FDA product code for X-Guide® Surgical Navigation System is QRY.

其他以 X-Nav Technologies, LLC 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。

K253954X-Guide 外科導航系統 K232148X-Guide 外科導航系統 K200662X-Guide® 外科導航系統 K192579X-Guide 外科導航系統

相關器械（代碼：QRY）

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。

K253954X-Guide 外科導航系統X-Nav Technologies, LLC K232148X-Guide 外科導航系統X-Nav Technologies, LLC K222750Yomi機器人系統Neocis, Inc.K222049Yomi機器人系統Neocis, Inc.

官方來源

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