FDA 510(k)

CMORE® CT系統；CMORE® CT系統導航儀器

K 號：K252327 · 2025-11-12

決定日期2025-11-12

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

CMORE® CT System; CMORE® CT System Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2025-11-12 under 510(k) number K252327. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CMORE® CT System; CMORE® CT System Navigated Instruments?

CMORE® CT System; CMORE® CT System Navigated Instruments is a medical device that received FDA 510(k) clearance on 2025-11-12. The listed applicant is Icotec AG. The 510(k) number is K252327.

When did CMORE® CT System; CMORE® CT System Navigated Instruments receive FDA 510(k) clearance?

CMORE® CT System; CMORE® CT System Navigated Instruments received FDA 510(k) clearance on 2025-11-12, under 510(k) number K252327.

Who is the listed applicant for CMORE® CT System; CMORE® CT System Navigated Instruments?

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

What is the FDA product code for CMORE® CT System; CMORE® CT System Navigated Instruments?

The FDA product code for CMORE® CT System; CMORE® CT System Navigated Instruments is NKG.

其他以 Icotec AG 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：NKG）

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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