510(k) K101757

SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM by Sonosite,Inc. — Product Code ITX

K101757 is an FDA 510(k) premarket notification submitted by Sonosite,Inc. for the device "SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on August 12, 2010. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Sonosite,Inc. has at least 10 other 510(k) clearances on record.