FDA 510(k)

Sistemas de Ultrasonido Diagnóstico ACUSON S1000/S2000/S3000

N.º K: K163635 · 2017-01-12

SolicitanteSiemens Medical Solutions USA, Inc. Ultrasound Group

Fecha de decisión2017-01-12

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc. Ultrasound Group. It received FDA 510(k) clearance on 2017-01-12 under 510(k) number K163635. 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 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems?

ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Siemens Medical Solutions USA, Inc. Ultrasound Group. The 510(k) number is K163635.

When did ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems receive FDA 510(k) clearance?

ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems received FDA 510(k) clearance on 2017-01-12, under 510(k) number K163635.

Who is the listed applicant for ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. Ultrasound Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems?

The FDA product code for ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems is IYN.

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Otros registros que enlistan a Siemens Medical Solutions USA, Inc. Ultrasound Group como solicitante

K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System

Dispositivos relacionados (Código: IYN)

Fuente oficial

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