FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

This product consists of ultrasonic probes used in diagnostic imaging. These probes emit and receive ultrasound waves to create images of the body's internal structures, helping clinicians visualize and assess patients non-invasively.

FDA #
K250762
Product Code
ITX

The Mendaera Guidance System is an ultrasonic diagnostic transducer designed to assist clinicians in medical imaging procedures by providing real-time ultrasound images. It helps healthcare providers visualize internal structures, aiding in diagnosis and treatment guidance.

FDA #
K250524
Product Code
ITX
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