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FDA 510(k)

EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System

N.º K: K201012 · 2020-05-01

SolicitantePhilips Ultrasound, Inc.
Fecha de decisión2020-05-01
Código de productoIYN
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K201012. 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 EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System?

EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K201012.

When did EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System receive FDA 510(k) clearance?

EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System received FDA 510(k) clearance on 2020-05-01, under 510(k) number K201012.

Who is the listed applicant for EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System?

The FDA 510(k) record lists Philips Ultrasound, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System?

The FDA product code for EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System is IYN.

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Otros registros que enlistan a Philips Ultrasound, Inc. como solicitante

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K212777Collaboration LiveK203406Lumify Diagnostic Ultrasound SystemK200603Modelo AAAK201665Collaboration LiveK202216EPIQ Series Diagnostic Ultrasound SystemsK201053PercuNav Image Fusion and Interventional Navigation

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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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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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