Mobile Adaptix Ortho350 gains FDA clearance
Adaptix has received 510(k) clearance from the USA FDA for its 3D imaging product, the Adaptix Ortho350. The mobile, low dose digital tomosynthesis orthopaedic system is designed to deliver fast, lower cost 3D x-rays at the point of care. It was developed specifically to image upper and lower extremities at a fraction of the radiation dose of traditional CT systems. The company says it provides clearer images than 2D x-ray systems, offering advantages in terms of fewer acquisitions, accelerated patient workflow and enhanced diagnostic accuracy.
CEO Sarah Small said: “Securing this FDA 510(k) clearance represents a significant milestone for Adaptix in our mission to transform radiology. We already have a great deal of interest from healthcare providers and clinicians for our revolutionary orthopaedic imaging system.”
Picture: the Adaptix Ortho350 low dose imaging system. Credit: Adaptix.
Read this report on page 15 of the January 2026 issue of RAD Magazine.
