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PMA de la FDA

Ablation system, high intensity focused ultrasound (HIFU), MR-guided

Número de PMA: P110039 · 2018-08-16

SolicitanteInsightec
Fecha de decisión2018-08-16
Número PMAP110039
Código de productoNRZ
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorSU

Resumen del dispositivo

Ablation system, high intensity focused ultrasound (HIFU), MR-guided is the device name listed in this FDA 510(k) record. The listed applicant is Insightec. It received FDA 510(k) clearance on 2018-08-16. The device is classified under product code NRZ. It was reviewed by the SU advisory panel.

Preguntas frecuentes

What is the Ablation system, high intensity focused ultrasound (HIFU), MR-guided?

Ablation system, high intensity focused ultrasound (HIFU), MR-guided is a medical device that received FDA 510(k) clearance on 2018-08-16. The listed applicant is Insightec.

When did Ablation system, high intensity focused ultrasound (HIFU), MR-guided receive FDA 510(k) clearance?

The clearance date for Ablation system, high intensity focused ultrasound (HIFU), MR-guided can be found in the official FDA records.

Who is the listed applicant for Ablation system, high intensity focused ultrasound (HIFU), MR-guided?

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

What is the FDA product code for Ablation system, high intensity focused ultrasound (HIFU), MR-guided?

The FDA product code for Ablation system, high intensity focused ultrasound (HIFU), MR-guided is NRZ.

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Fuente oficial

Ver en la base de datos de la FDA →

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