Deep Learning Image Reconstruction for Gemstone Spectral Imaging

Deep Learning Image Reconstruction for Gemstone Spectral Imaging is an FDA 510(k)-cleared medical device (K201745) manufactured by Ge Medical Systems, 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 December 9, 2020. Regulation: 8.