ASUS Handheld Ultrasound LU800 Receives US FDA-510(k) Clearance
First ASUS Class II medical device in the US market is a milestone and accelerates global expansion of intelligent ASUS healthcare solutions
TAIPEI, Taiwan, January 12, 2026 — ASUS today announced that the ASUS Handheld Ultrasound LU800 has received 510(k) clearance from the US Food and Drug Administration (FDA). This landmark achievement for a Class II medical device signifies the company's formal entry into the US medical device market and reinforces its commitment to advancing intelligent healthcare solutions.
FDA 510(k) clearance is a globally recognized benchmark that confirms that the ASUS Handheld Ultrasound LU800 is safe, effective, and substantially equivalent to predicate devices. FDA clearance validates the LU800’s performance and confirms adherence to stringent FDA quality management and regulatory standards, providing a credential trusted by healthcare institutions worldwide.
The versatile ASUS Handheld Ultrasound LU800 is a lightweight wireless handheld ultrasound system that’s ideal for point-of-care ultrasound (POCUS). Its compact design makes it suitable for use in a wide range of clinical environments — from emergency rooms and ambulances to rural clinics. It features a 128-channel beamformer, five imaging modes, and DICOM support to deliver high-quality ultrasound imaging and rapid measurements to significantly enhance diagnostic efficiency for healthcare professionals. It is also the world’s first handheld ultrasound to offer support across four major operating systems — Android, iOS, Chrome, and Windows — transforming hardware to future-proof diagnostic assistance platform.
"The successful FDA clearance of the LU800 handheld wireless ultrasound is more than just a regulatory milestone; it is a tangible affirmation of our long-term commitment to smart healthcare R&D," said Joe Hsieh, ASUS COO and SVP. "As a medical solutions provider with deep technological expertise, ASUS remains dedicated to placing clinical needs at the core of our innovation. By integrating AI algorithms, wireless communication technology, medical imaging, and system integration capabilities, we are committed to developing real-time, high-quality, and easy-to-deploy medical imaging tools that empower physicians and healthcare teams to enhance diagnostic efficiency and patient care quality. Additionally, we are advancing the development of AI-guided ultrasound scanning applications, which offer real-time operational guidance throughout the scanning process, assisting users in acquiring clinically relevant image quality. This innovation lowers the technical barrier for ultrasound operation, enabling more non-specialist users to effectively utilize this tool."
ASUS will leverage the US FDA clearance of the Handheld Ultrasound LU800 to accelerate global deployment of its handheld ultrasound solutions, expanding into key regions with growing demand for smart and remote healthcare — including Southeast Asia and South America — to broaden access to advanced medical technology.
