NOBLUS DIAGNOSTIC ULTRASOUND SCANNER

NOBLUS DIAGNOSTIC ULTRASOUND SCANNER is an FDA 510(k)-cleared medical device (K142368) 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 January 13, 2015. Regulation: 8.