ARIETTA Prologue Diagnostic Ultrasound system and Transducers

ARIETTA Prologue Diagnostic Ultrasound system and Transducers is an FDA 510(k)-cleared medical device (K162902) manufactured by Hitachi , 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 December 14, 2016. Regulation: 8.