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PMA de la FDA

MR-guided focused ultrasound system

Número de PMA: P150038 · 2026-09-16

SolicitanteInsightec
Fecha de decisión2026-09-16
Número PMAP150038
Código de productoPOH
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorNE

Resumen del dispositivo

MR-guided focused ultrasound system is the device name listed in this FDA 510(k) record. The listed applicant is Insightec. It received FDA 510(k) clearance on 2026-09-16. The device is classified under product code POH. It was reviewed by the NE advisory panel.

Preguntas frecuentes

What is the MR-guided focused ultrasound system?

MR-guided focused ultrasound system is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Insightec.

When did MR-guided focused ultrasound system receive FDA 510(k) clearance?

The clearance date for MR-guided focused ultrasound system can be found in the official FDA records.

Who is the listed applicant for MR-guided focused ultrasound system?

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 MR-guided focused ultrasound system?

The FDA product code for MR-guided focused ultrasound system is POH.

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Fuente oficial

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