As a long-time certified brand in the medical tech equipment world, ASUS has announced that its Handheld Ultrasound LU800 has officially received 510(k) clearance from the US FDA department.
The LU800 is a lightweight, wireless handheld ultrasound designed for point-of-care ultrasound, meaning it’s built to be used directly where patients are, whether that’s in emergency rooms, ambulances, rural clinics, or other fast-moving clinical environments. Despite the compact form factor, it houses a 128-channel beamformer, 5 imaging modes, and DICOM support, all aimed at delivering high-quality imaging and faster measurements to improve diagnostic efficiency. On top of that, ASUS says it’s the world’s first handheld ultrasound to support major OS, including Android, iOS, Chrome, and Windows.
With the US clearance secured, ASUS says it plans to use this as a launchpad for broader global expansion, targeting regions with growing demand for smart and remote healthcare solutions, including Southeast Asia and South America, with the broader goal of expanding access to advanced medical technology where it’s needed most.
