FDA 510(k)

ASUS 超聲成像系統（LU800 系列型號）

K 號：K250791 · 2025-12-04

決定日期2025-12-04

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

ASUS Ultrasound Imaging System (LU800 series) is the device name listed in this FDA 510(k) record. The listed applicant is Asustek Computer, Inc.. It received FDA 510(k) clearance on 2025-12-04 under 510(k) number K250791. 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 ASUS Ultrasound Imaging System (LU800 series)?

ASUS Ultrasound Imaging System (LU800 series) is a medical device that received FDA 510(k) clearance on 2025-12-04. The listed applicant is Asustek Computer, Inc.. The 510(k) number is K250791.

When did ASUS Ultrasound Imaging System (LU800 series) receive FDA 510(k) clearance?

ASUS Ultrasound Imaging System (LU800 series) received FDA 510(k) clearance on 2025-12-04, under 510(k) number K250791.

Who is the listed applicant for ASUS Ultrasound Imaging System (LU800 series)?

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

What is the FDA product code for ASUS Ultrasound Imaging System (LU800 series)?

The FDA product code for ASUS Ultrasound Imaging System (LU800 series) is IYN.

相關器械（代碼：IYN）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：IYN）

官方來源