Rivanna Medical, Inc. - FDA 510(k) Cleared Devices

Rivanna Medical, Inc. develops AI-powered clinical decision-support platforms for Radiology imaging and procedural guidance. The company is headquartered in Charlottesville, Virginia, with an FDA-registered, ISO 13485:2016-certified manufacturing facility. Rivanna's proprietary technology automates complex anatomical analysis at the point of care, enabling faster clinical decisions while reducing operator variability.

The company has received 3 FDA 510(k) clearances from 3 total submissions, with all submissions focused on Radiology devices. First clearance was in 2025, and the most recent clearance occurred in 2026, demonstrating active regulatory engagement. The cleared portfolio includes the Accuro XV diagnostic ultrasound system, Accuro 3S platform with AI-powered spinal navigation software, and associated needle guide consumables.

Rivanna's platform integrates proprietary deep learning models, robotic 3D transducer technology, and real-time needle tracking via SafeTrack™ technology. Primary applications target neuraxial anesthesia guidance and point-of-care musculoskeletal imaging in emergency medicine. The company has received government validation through NIH partnerships and ongoing collaboration with BARDA for fracture detection algorithm development.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the 510(k) database.