LOGIQ E10s, LOGIQ Fortis

LOGIQ E10s, LOGIQ Fortis is an FDA 510(k)-cleared medical device (K211524) manufactured by GE Healthcare. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2021. Regulation: 8.