FDA PMA

Automated breast ultrasound

PMA Number: P110006 · 2025-02-04

ApplicantGE Healthcare

Decision Date2025-02-04

PMA NumberP110006

Product CodePAA

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeRA

Device Summary

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.

Frequently Asked Questions

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.

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.