FDA PMA

Analisador, imagem médica

Número do PMA: P150043 · 2017-12-14

RequerenteQview Medical, Inc.

Data da decisão2017-12-14

Número PMAP150043

Código do produtoMYN

Classe do DispositivoClasse 2

Especialidade MédicaR

Número da Regulamentação21 CFR 8

Comité consultivoRA

Resumo do dispositivo

Analyzer, medical image is the device name listed in this FDA 510(k) record. The listed applicant is Qview Medical, Inc.. It received FDA 510(k) clearance on 2017-12-14. The device is classified under product code MYN. It was reviewed by the RA advisory panel.

Perguntas frequentes

What is the Analyzer, medical image?

Analyzer, medical image is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Qview Medical, Inc..

When did Analyzer, medical image receive FDA 510(k) clearance?

The clearance date for Analyzer, medical image can be found in the official FDA records.

Who is the listed applicant for Analyzer, medical image?

The FDA 510(k) record lists Qview Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Analyzer, medical image?

The FDA product code for Analyzer, medical image is MYN.

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