FDA 510(k)

ASUS超音波画像診断システム（LU800シリーズ）

K番号: K250791 · 2025-12-04

決定日2025-12-04

製品コードIYN

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

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ASUS超音波画像診断システム（LU800シリーズ）

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：IYN）

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