510(k) K254021

Accuro XV by Rivanna Medical, Inc. — Product Code IYO

K254021 is an FDA 510(k) premarket notification submitted by Rivanna Medical, Inc. for the device "Accuro XV". The FDA issued a decision of Substantially Equivalent on April 9, 2026. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Rivanna Medical, Inc. has at least 4 other 510(k) clearances on record.