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FDA PMA

MR-guided focused ultrasound system

PMA Number: P150038 · 2026-09-16

ApplicantInsightec
Decision Date2026-09-16
PMA NumberP150038
Product CodePOH
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeNE

Device Summary

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.

Frequently Asked Questions

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.

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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