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PMA de la FDA

Digital breast tomosynthesis

Número de PMA: P160031 · 2023-02-13

SolicitanteFujifilm Medical Systems U.S.A, Inc.
Fecha de decisión2023-02-13
Número PMAP160031
Código de productoOTE
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorRA

Resumen del dispositivo

Digital breast tomosynthesis 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 2023-02-13. The device is classified under product code OTE. It was reviewed by the RA advisory panel.

Preguntas frecuentes

What is the Digital breast tomosynthesis?

Digital breast tomosynthesis is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Fujifilm Medical Systems U.S.A, Inc..

When did Digital breast tomosynthesis receive FDA 510(k) clearance?

The clearance date for Digital breast tomosynthesis can be found in the official FDA records.

Who is the listed applicant for Digital breast tomosynthesis?

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 Digital breast tomosynthesis?

The FDA product code for Digital breast tomosynthesis is OTE.

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Fuente oficial

Ver en la base de datos de la FDA →

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