FDA 510(k)

CORUS™導航系統-GX

K 號：K251060 · 2025-07-30

決定日期2025-07-30

產品代碼OLO

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

CORUS™ Navigation System-GX is the device name listed in this FDA 510(k) record. The listed applicant is Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2025-07-30 under 510(k) number K251060. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CORUS™ Navigation System-GX?

CORUS™ Navigation System-GX is a medical device that received FDA 510(k) clearance on 2025-07-30. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K251060.

When did CORUS™ Navigation System-GX receive FDA 510(k) clearance?

CORUS™ Navigation System-GX received FDA 510(k) clearance on 2025-07-30, under 510(k) number K251060.

Who is the listed applicant for CORUS™ Navigation System-GX?

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

What is the FDA product code for CORUS™ Navigation System-GX?

The FDA product code for CORUS™ Navigation System-GX is OLO.

其他以 Providence Medical Technology, 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。

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相關器械（代碼：OLO）

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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