FDA 510(k)

Sistema de Gestão de Imagens AXIS

Número K: K171098 · 2017-05-02

Data da decisão2017-05-02

Código do produtoNFJ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

AXIS Image Management System is the device name listed in this FDA 510(k) record. The listed applicant is Sonomed, Inc.. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K171098. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AXIS Image Management System?

AXIS Image Management System is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Sonomed, Inc.. The 510(k) number is K171098.

When did AXIS Image Management System receive FDA 510(k) clearance?

AXIS Image Management System received FDA 510(k) clearance on 2017-05-02, under 510(k) number K171098.

Who is the listed applicant for AXIS Image Management System?

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

What is the FDA product code for AXIS Image Management System?

The FDA product code for AXIS Image Management System is NFJ.

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