Healium Intelliscan LX192LC

Healium Intelliscan LX192LC is an FDA 510(k)-cleared medical device (K261132) manufactured by Healium Intelliscan Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 4, 2026. Regulation: 8.