Voluson SWIFT; Voluson SWIFT+

Voluson SWIFT; Voluson SWIFT+ is an FDA 510(k)-cleared medical device (K230346) manufactured by Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 2023. Regulation: 8.