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FDA PMA

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

PMA Number: P040003 · 2025-07-23

ApplicantInsightec, Ltd.
Decision Date2025-07-23
PMA NumberP040003
Product CodeNRZ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOB

Device Summary

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, Ltd.. It received FDA 510(k) clearance on 2025-07-23. The device is classified under product code NRZ. It was reviewed by the OB advisory panel.

Frequently Asked Questions

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 2025-07-23. The listed applicant is Insightec, Ltd..

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, Ltd. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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