510(k) K081843

ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 by Aloka Co., Ltd. — Product Code LLZ

K081843 is an FDA 510(k) premarket notification submitted by Aloka Co., Ltd. for the device "ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1". The FDA issued a decision of Substantially Equivalent on July 15, 2008. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Aloka Co., Ltd. has at least 10 other 510(k) clearances on record.