ASUS announced that its Handheld Ultrasound LU800 has received 510(k) clearance from the US Food and Drug Administration. This marks ASUS’s first Class II medical device clearance in the United States and represents its formal entry into the US medical device market.
FDA 510(k) clearance confirms that the LU800 meets safety effectiveness and quality standards and is substantially equivalent to existing approved devices. The clearance is recognized globally and supports use by healthcare institutions.
The ASUS LU800 is a wireless handheld ultrasound system designed for point of care use. It is lightweight and suitable for settings such as emergency rooms ambulances and rural clinics. The device includes a 128 channel beamformer five imaging modes and DICOM support to assist with fast and reliable imaging.
The LU800 supports Android iOS Chrome and Windows making it compatible across major operating systems. ASUS plans to use the US clearance to expand deployment of its handheld ultrasound solutions in other regions including Southeast Asia and South America.
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