Insight Enhanced™ DRF (EN-1002-01)

Insight Enhanced™ DRF (EN-1002-01) is an FDA 510(k)-cleared medical device (K251650) 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 September 15, 2025. Regulation: 8.