FDA 510(k)

BI IMAGE-X EVOLUTION

Número K: K160458 · 2016-06-20

RequerenteRadiotecnologia Industrial S.A. DE C.V.

Data da decisão2016-06-20

Código do produtoEHD

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

BI IMAGE-X EVOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Radiotecnologia Industrial S.A. DE C.V.. It received FDA 510(k) clearance on 2016-06-20 under 510(k) number K160458. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BI IMAGE-X EVOLUTION?

BI IMAGE-X EVOLUTION is a medical device that received FDA 510(k) clearance on 2016-06-20. The listed applicant is Radiotecnologia Industrial S.A. DE C.V.. The 510(k) number is K160458.

When did BI IMAGE-X EVOLUTION receive FDA 510(k) clearance?

BI IMAGE-X EVOLUTION received FDA 510(k) clearance on 2016-06-20, under 510(k) number K160458.

Who is the listed applicant for BI IMAGE-X EVOLUTION?

The FDA 510(k) record lists Radiotecnologia Industrial S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BI IMAGE-X EVOLUTION?

The FDA product code for BI IMAGE-X EVOLUTION is EHD.

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