FDA 510(k)

CAAS MR 4D Flow

Número K: K162376 · 2016-12-08

Data da decisão2016-12-08

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

CAAS MR 4D Flow is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Imaging BV. It received FDA 510(k) clearance on 2016-12-08 under 510(k) number K162376. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CAAS MR 4D Flow?

CAAS MR 4D Flow is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K162376.

When did CAAS MR 4D Flow receive FDA 510(k) clearance?

CAAS MR 4D Flow received FDA 510(k) clearance on 2016-12-08, under 510(k) number K162376.

Who is the listed applicant for CAAS MR 4D Flow?

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

What is the FDA product code for CAAS MR 4D Flow?

The FDA product code for CAAS MR 4D Flow is LLZ.

Outros registros que listam Pie Medical Imaging BV como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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