Insight Essentials DRF Digital Imaging System

Insight Essentials DRF Digital Imaging System is an FDA 510(k)-cleared medical device (K191310) manufactured by Imaging Engineering, 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 June 9, 2019. Regulation: 8.