FDA 510(k)

診斷超音波系統（Nano C5、Nano C5 EXP、Nano L12 及 Nano L12 EXP）

K 號：K251268 · 2025-12-23

決定日期2025-12-23

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K251268. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K251268.

When did Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) receive FDA 510(k) clearance?

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K251268.

Who is the listed applicant for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

FDA 510(k) 記錄將 Edan Instruments, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

The FDA product code for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is IYN.

其他以 Edan Instruments, 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：IYN）

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。

官方來源

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