510(k) K230346

Voluson SWIFT; Voluson SWIFT+ by Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC — Product Code IYN

K230346 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC for the device "Voluson SWIFT; Voluson SWIFT+". The FDA issued a decision of Substantially Equivalent on June 20, 2023. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC has at least 2 other 510(k) clearances on record.