FDA 510(k)

FDX Console (DR-ID300CL) Software

N.º K: K170451 · 2017-03-16

SolicitanteFujifilm Medical Systems U.S.A, Inc.

Fecha de decisión2017-03-16

Código de productoLLZ

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

FDX Console (DR-ID300CL) Software 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 2017-03-16 under 510(k) number K170451. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FDX Console (DR-ID300CL) Software?

FDX Console (DR-ID300CL) Software is a medical device that received FDA 510(k) clearance on 2017-03-16. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K170451.

When did FDX Console (DR-ID300CL) Software receive FDA 510(k) clearance?

FDX Console (DR-ID300CL) Software received FDA 510(k) clearance on 2017-03-16, under 510(k) number K170451.

Who is the listed applicant for FDX Console (DR-ID300CL) Software?

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 FDX Console (DR-ID300CL) Software?

The FDA product code for FDX Console (DR-ID300CL) Software is LLZ.

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Otros registros que enlistan a Fujifilm Medical Systems U.S.A, Inc. como solicitante

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.