NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM

NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM is an FDA 510(k)-cleared medical device (K130308) manufactured by Hitachi Aloka Medical, Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 4, 2013. Regulation: 8.