FDA 510(k)

Sentinella 102, Sentinella 102 Horus

Número K: K162052 · 2016-08-18

RequerenteGeneral Equipment For Medical Imaging (Oncovision-

Data da decisão2016-08-18

Código do produtoIYX

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sentinella 102, Sentinella 102 Horus is the device name listed in this FDA 510(k) record. The listed applicant is General Equipment For Medical Imaging (Oncovision-. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K162052. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sentinella 102, Sentinella 102 Horus?

Sentinella 102, Sentinella 102 Horus is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is General Equipment For Medical Imaging (Oncovision-. The 510(k) number is K162052.

When did Sentinella 102, Sentinella 102 Horus receive FDA 510(k) clearance?

Sentinella 102, Sentinella 102 Horus received FDA 510(k) clearance on 2016-08-18, under 510(k) number K162052.

Who is the listed applicant for Sentinella 102, Sentinella 102 Horus?

The FDA 510(k) record lists General Equipment For Medical Imaging (Oncovision- as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sentinella 102, Sentinella 102 Horus?

The FDA product code for Sentinella 102, Sentinella 102 Horus is IYX.

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