510(k) K233610

ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System by Siemens Medical Solutions USA, Inc. — Product Code IYN

K233610 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System". The FDA issued a decision of Substantially Equivalent on June 12, 2024. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.