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510(k) approval for Biosound's ultrasound system:

This article was originally published in Clinica

Executive Summary

Biosound Esaote has received 510(k) clearance from the FDA for its AU5 ultrasound system. The AU5 is designed to support linear, curved and phased-array transducers and provides high-frequency superficial imaging capabilities. The device can be used for vascular, intraoperative, obstetrics, gynaecology, and intracavity imaging applications.

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