FDA 510(k)

Xario 200 Diagnostic Ultrasound System V6.0

Número K: K172276 · 2017-12-12

RequerenteToshibamedical Systems Corporation

Data da decisão2017-12-12

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Xario 200 Diagnostic Ultrasound System V6.0 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 2017-12-12 under 510(k) number K172276. 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 V6.0?

Xario 200 Diagnostic Ultrasound System V6.0 is a medical device that received FDA 510(k) clearance on 2017-12-12. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K172276.

When did Xario 200 Diagnostic Ultrasound System V6.0 receive FDA 510(k) clearance?

Xario 200 Diagnostic Ultrasound System V6.0 received FDA 510(k) clearance on 2017-12-12, under 510(k) number K172276.

Who is the listed applicant for Xario 200 Diagnostic Ultrasound System V6.0?

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 V6.0?

The FDA product code for Xario 200 Diagnostic Ultrasound System V6.0 is IYN.

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Fonte oficial

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