FDA Clears RIVANNA's Accuro XV Volumetric Ultrasound for Musculoskeletal Imaging

The US Food and Drug Administration has cleared RIVANNA's Accuro XV, a cart-based ultrasound system that automates wide-field scans of bones and soft tissue, the Charlottesville, Virginia, company said in a May 7 release posted on its website.

The FDA's 510(k) database lists the clearance as K254021, a traditional 510(k) received on December 16, 2025, with a substantially equivalent decision on April 9, 2026. The device is classified as a pulsed echo ultrasonic imaging system under product code IYO and was reviewed by the radiology panel.

What the clearance covers

According to the clearance letter and 510(k) summary, the Accuro XV is for use by qualified and trained healthcare professionals and "supports B-mode imaging for clinical applications that include: musculoskeletal conventional and superficial." Its probe is described as a conformable three-dimensional probe that automates large field-of-view image acquisitions after the patient is first positioned.

RIVANNA named its own Accuro 3S as the predicate device and the Logiq E9 as a reference device. The summary says the key difference from the predicate is the volumetric imaging probe; other differences include the cart design, computer hardware and user interface. Testing listed covers acoustic output, cleaning and disinfection, electrical, thermal, mechanical and electromagnetic safety, biocompatibility and usability. The summary states that the submission "did not require clinical studies to support the determination of substantial equivalence."

The company said the system's motorized probe acquires B-mode images over a 10 cm scan extent, with a polyurethane stand-off that conforms to irregular anatomy. The cart has a touchscreen, a built-in battery and DICOM-compatible image archiving.

Software still in development

The clearance covers imaging only. RIVANNA said it is developing two machine learning modules for the platform: BoneEnhance, which segments bone for 3D visualization, and a computer-aided detection tool for fractures. Both are being trained and validated in an ongoing study at eight academic medical centers, the company said, and it described them as "advancing toward FDA clearance."

"FDA clearance of the Accuro XV marks a major inflection point for RIVANNA," said Will Mauldin, the company's co-founder and chief executive. RIVANNA is pitching the system for emergency department triage of low-severity limb injuries, with the aim of reducing reliance on X-ray referrals.

The company also pointed to a feasibility study at UVA Health and UT Southwestern Medical Center, published in the Journal of Emergency Medicine, that it said enrolled 205 patients. According to RIVANNA, non-physician operators with one hour of hands-on training acquired images of quality comparable to board-certified emergency physicians, and more than 90% of scans in both groups were rated adequate for diagnostic interpretation.

The release said the project has been supported with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services, under contract 75A50121C00035. It did not give a launch date or price.