FDA 510(k)

ASUS Ultrasound Imaging System (LU800 series)

K-Number: K250791 · 2025-12-04

Decision Date2025-12-04

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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