MobileRay Pulse SE Digital Imaging System

MobileRay Pulse SE Digital Imaging System is an FDA 510(k)-cleared medical device (K191503) manufactured by Portavision Medical, 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 September 3, 2019. Regulation: 8.