FDA 510(k)

Xario 200 Diagnostic Ultrasound System V5.0

Número K: K162155 · 2016-11-01

RequerenteToshibamedical Systems Corporation

Data da decisão2016-11-01

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Xario 200 Diagnostic Ultrasound System V5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K162155. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Xario 200 Diagnostic Ultrasound System V5.0?

Xario 200 Diagnostic Ultrasound System V5.0 is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K162155.

When did Xario 200 Diagnostic Ultrasound System V5.0 receive FDA 510(k) clearance?

Xario 200 Diagnostic Ultrasound System V5.0 received FDA 510(k) clearance on 2016-11-01, under 510(k) number K162155.

Who is the listed applicant for Xario 200 Diagnostic Ultrasound System V5.0?

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

What is the FDA product code for Xario 200 Diagnostic Ultrasound System V5.0?

The FDA product code for Xario 200 Diagnostic Ultrasound System V5.0 is IYN.

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Fonte oficial

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