FDA 510(k)

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)

Número K: K163624 · 2017-06-30

RequerenteFujifilm Medical Systems U.S.A, Inc.

Data da decisão2017-06-30

Código do produtoMQB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-06-30 under 510(k) number K163624. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)?

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K163624.

When did Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) receive FDA 510(k) clearance?

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) received FDA 510(k) clearance on 2017-06-30, under 510(k) number K163624.

Who is the listed applicant for Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)?

The FDA product code for Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is MQB.

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