510(k) K020561

SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN by Tomtec Imaging Systems GmbH — Product Code IYO

K020561 is an FDA 510(k) premarket notification submitted by Tomtec Imaging Systems GmbH for the device "SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN". The FDA issued a decision of Substantially Equivalent on May 9, 2002. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Tomtec Imaging Systems GmbH has at least 10 other 510(k) clearances on record.