510(k) K022567

SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM by Acuson Corp. — Product Code IYN

K022567 is an FDA 510(k) premarket notification submitted by Acuson Corp. for the device "SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on August 13, 2002. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Acuson Corp. has at least 10 other 510(k) clearances on record.