FDA 510(k)

Volumetric Specimen Imager

Número K: K192939 · 2019-12-27

Data da decisão2019-12-27

Código do produtoMWP

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Volumetric Specimen Imager is the device name listed in this FDA 510(k) record. The listed applicant is Clarix Imaging. It received FDA 510(k) clearance on 2019-12-27 under 510(k) number K192939. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Volumetric Specimen Imager?

Volumetric Specimen Imager is a medical device that received FDA 510(k) clearance on 2019-12-27. The listed applicant is Clarix Imaging. The 510(k) number is K192939.

When did Volumetric Specimen Imager receive FDA 510(k) clearance?

Volumetric Specimen Imager received FDA 510(k) clearance on 2019-12-27, under 510(k) number K192939.

Who is the listed applicant for Volumetric Specimen Imager?

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

What is the FDA product code for Volumetric Specimen Imager?

The FDA product code for Volumetric Specimen Imager is MWP.

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