510(k) K072541

SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM by Senorx, Inc. — Product Code ITX

K072541 is an FDA 510(k) premarket notification submitted by Senorx, Inc. for the device "SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 25, 2007. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Senorx, Inc. has at least 10 other 510(k) clearances on record.