510(k) K014168

AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) by Biosound Esaote, Inc. — Product Code IYN

K014168 is an FDA 510(k) premarket notification submitted by Biosound Esaote, Inc. for the device "AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)". The FDA issued a decision of Substantially Equivalent on April 25, 2002. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Biosound Esaote, Inc. has at least 10 other 510(k) clearances on record.