Saige-Dx (3.1.0)

Saige-Dx (3.1.0) is an FDA 510(k)-cleared medical device (K243688) manufactured by DeepHealth, Inc.. 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 18, 2024. Regulation: 8.