Versana Premier; Versana Premier Lotus; LOGIQ F

Versana Premier; Versana Premier Lotus; LOGIQ F is an FDA 510(k)-cleared medical device (K242005) manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 1, 2024. Regulation: 8.