VistaScan USB Ultrasound Imaging System

VistaScan USB Ultrasound Imaging System is an FDA 510(k)-cleared medical device (K192170) manufactured by Emagine Solutions Technology, LLC. 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 22, 2020. Regulation: 8.