FDA 510(k)

NOBLUS™ Ultrasound Diagnostic System

N.º K: K160559 · 2016-10-18

Fecha de decisión2016-10-18

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

NOBLUS™ Ultrasound Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Corporation. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K160559. 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 NOBLUS™ Ultrasound Diagnostic System?

NOBLUS™ Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Hitachi Medical Corporation. The 510(k) number is K160559.

When did NOBLUS™ Ultrasound Diagnostic System receive FDA 510(k) clearance?

NOBLUS™ Ultrasound Diagnostic System received FDA 510(k) clearance on 2016-10-18, under 510(k) number K160559.

Who is the listed applicant for NOBLUS™ Ultrasound Diagnostic System?

The FDA 510(k) record lists Hitachi Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOBLUS™ Ultrasound Diagnostic System?

The FDA product code for NOBLUS™ Ultrasound Diagnostic System is IYN.

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Dispositivos relacionados (Código: IYN)

Fuente oficial

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