510(k) K040719

ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY by Aloka Co., Ltd. — Product Code IYO

K040719 is an FDA 510(k) premarket notification submitted by Aloka Co., Ltd. for the device "ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY". The FDA issued a decision of Substantially Equivalent on March 26, 2004. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Aloka Co., Ltd. has at least 10 other 510(k) clearances on record.