FDA 510(k)

Biograph Horizon

N.º K: K193178 · 2020-02-12

SolicitanteSiemens Medical Solution USA, Inc.

Fecha de decisión2020-02-12

Código de productoKPS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Biograph Horizon is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solution USA, Inc.. It received FDA 510(k) clearance on 2020-02-12 under 510(k) number K193178. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Biograph Horizon?

Biograph Horizon is a medical device that received FDA 510(k) clearance on 2020-02-12. The listed applicant is Siemens Medical Solution USA, Inc.. The 510(k) number is K193178.

When did Biograph Horizon receive FDA 510(k) clearance?

Biograph Horizon received FDA 510(k) clearance on 2020-02-12, under 510(k) number K193178.

Who is the listed applicant for Biograph Horizon?

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

What is the FDA product code for Biograph Horizon?

The FDA product code for Biograph Horizon is KPS.

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Fuente oficial

Ver en la base de datos de la FDA →

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