510(k) K243227

B-Scan by Accutome, Inc. Doing Business AS Keeler USA — Product Code IYO

K243227 is an FDA 510(k) premarket notification submitted by Accutome, Inc. Doing Business AS Keeler USA for the device "B-Scan". The FDA issued a decision of Substantially Equivalent on July 11, 2025. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.