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FDA 510(k)

ASUS Ultrasound Imaging System (LU800 series)

K-Number: K250791 · 2025-12-04

ApplicantAsustek Computer, Inc.
Decision Date2025-12-04
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ASUS Ultrasound Imaging System (LU800 series) is a medical device manufactured by Asustek Computer, Inc.. It received FDA 510(k) clearance on 2025-12-04 under approval 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. It is manufactured by Asustek Computer, Inc.. The 510(k) number is K250791.

When was ASUS Ultrasound Imaging System (LU800 series) approved by the FDA?

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

What company makes ASUS Ultrasound Imaging System (LU800 series)?

ASUS Ultrasound Imaging System (LU800 series) is manufactured by Asustek Computer, Inc..

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 Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025)

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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