FDA 510(k)

Xario 100 Diagnostic Ultrasound System, V5.0

Número K: K162187 · 2016-09-30

RequerenteToshibamedical Systems Corporation

Data da decisão2016-09-30

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Xario 100 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 2016-09-30 under 510(k) number K162187. 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 100 Diagnostic Ultrasound System, V5.0?

Xario 100 Diagnostic Ultrasound System, V5.0 is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K162187.

When did Xario 100 Diagnostic Ultrasound System, V5.0 receive FDA 510(k) clearance?

Xario 100 Diagnostic Ultrasound System, V5.0 received FDA 510(k) clearance on 2016-09-30, under 510(k) number K162187.

Who is the listed applicant for Xario 100 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 100 Diagnostic Ultrasound System, V5.0?

The FDA product code for Xario 100 Diagnostic Ultrasound System, V5.0 is IYN.

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Fonte oficial

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