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FDA 510(k)

Voluson SWIFT; Voluson SWIFT+

N.º K: K230346 · 2023-06-20

SolicitanteGe Medical Systems Ultrasound & Primary Care Diagnostic, LLC
Fecha de decisión2023-06-20
Código de productoIYN
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

Voluson SWIFT; Voluson SWIFT+ is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K230346. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Voluson SWIFT; Voluson SWIFT+?

Voluson SWIFT; Voluson SWIFT+ is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC. The 510(k) number is K230346.

When did Voluson SWIFT; Voluson SWIFT+ receive FDA 510(k) clearance?

Voluson SWIFT; Voluson SWIFT+ received FDA 510(k) clearance on 2023-06-20, under 510(k) number K230346.

Who is the listed applicant for Voluson SWIFT; Voluson SWIFT+?

The FDA 510(k) record lists Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voluson SWIFT; Voluson SWIFT+?

The FDA product code for Voluson SWIFT; Voluson SWIFT+ is IYN.

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Dispositivos relacionados (Código: IYN)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsK254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)Sonoscape Medical Corp.K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Sistema de Ultrasonido Diagnóstico de la Serie AlturionPhilips Ultrasound, LLC

Fuente oficial

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