Voluson SWIFT, Voluson SWIFT+

Voluson SWIFT, Voluson SWIFT+ is an FDA 510(k)-cleared medical device (K201828) 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 10, 2020. Regulation: 8.