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PMA de la FDA

Automated breast ultrasound

Número de PMA: P110006 · 2025-02-04

SolicitanteGE Healthcare
Fecha de decisión2025-02-04
Número PMAP110006
Código de productoPAA
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorRA

Resumen del dispositivo

Automated breast ultrasound is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2025-02-04. The device is classified under product code PAA. It was reviewed by the RA advisory panel.

Preguntas frecuentes

What is the Automated breast ultrasound?

Automated breast ultrasound is a medical device that received FDA 510(k) clearance on 2025-02-04. The listed applicant is GE Healthcare.

When did Automated breast ultrasound receive FDA 510(k) clearance?

The clearance date for Automated breast ultrasound can be found in the official FDA records.

Who is the listed applicant for Automated breast ultrasound?

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

What is the FDA product code for Automated breast ultrasound?

The FDA product code for Automated breast ultrasound is PAA.

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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.

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