FDA 510(k)

CMN 靜脈功能檢查儀，配備虛擬專家功能，適用於 MRI、CT 及 CBCT

K 號：K253831 · 2026-05-18

決定日期2026-05-18

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT is the device name listed in this FDA 510(k) record. The listed applicant is Cercare Medical A/S. It received FDA 510(k) clearance on 2026-05-18 under 510(k) number K253831. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CMN Capillary Function with Virtual Expert for MRI, CT and CBCT?

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT is a medical device that received FDA 510(k) clearance on 2026-05-18. The listed applicant is Cercare Medical A/S. The 510(k) number is K253831.

When did CMN Capillary Function with Virtual Expert for MRI, CT and CBCT receive FDA 510(k) clearance?

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT received FDA 510(k) clearance on 2026-05-18, under 510(k) number K253831.

Who is the listed applicant for CMN Capillary Function with Virtual Expert for MRI, CT and CBCT?

The FDA 510(k) record lists Cercare Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMN Capillary Function with Virtual Expert for MRI, CT and CBCT?

The FDA product code for CMN Capillary Function with Virtual Expert for MRI, CT and CBCT is LLZ.

其他以 Cercare Medical A/S 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。

K260316CMN 靜脈功能與腫瘤學虛擬專家 K241989Cercare醫療神經套件（CMN）微血管功能與虛擬專家 K230016Cercare醫療神經套件

相關器械（代碼：LLZ）

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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