510(k) K243937

Accuro 3S by Rivanna Medical, Inc. — Product Code IYO

K243937 is an FDA 510(k) premarket notification submitted by Rivanna Medical, Inc. for the device "Accuro 3S". The FDA issued a decision of Substantially Equivalent on May 23, 2025. 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 6 other 510(k) clearances on record.