FDA 510(k)

Navient影像導引導航系統（耳鼻喉科）（955-NC-NC）

K 號：K243053 · 2025-06-20

決定日期2025-06-20

產品代碼PGW

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

Navient Image Guided Navigation System (ENT) (955-NC-NC) is the device name listed in this FDA 510(k) record. The listed applicant is Claronav. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K243053. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Navient Image Guided Navigation System (ENT) (955-NC-NC)?

Navient Image Guided Navigation System (ENT) (955-NC-NC) is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Claronav. The 510(k) number is K243053.

When did Navient Image Guided Navigation System (ENT) (955-NC-NC) receive FDA 510(k) clearance?

Navient Image Guided Navigation System (ENT) (955-NC-NC) received FDA 510(k) clearance on 2025-06-20, under 510(k) number K243053.

Who is the listed applicant for Navient Image Guided Navigation System (ENT) (955-NC-NC)?

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

What is the FDA product code for Navient Image Guided Navigation System (ENT) (955-NC-NC)?

The FDA product code for Navient Image Guided Navigation System (ENT) (955-NC-NC) is PGW.

其他以 Claronav 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。

K241327Navient影像導航系統（955-NC-NC），頭部

相關器械（代碼：PGW）

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。

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官方來源

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