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.

The Aulisa Infant Oximeter Module (2nd Gen.) is a wireless, foot-worn sensor device designed to continuously measure oxygen saturation (SpO2) and pulse rate in infants. It sends the measured data via Bluetooth to a mobile device running a dedicated app for display and monitoring. This helps caregivers monitor infant vital signs in hospitals, home care, and medical facilities non-invasively in real time, with visual and auditory alarms for abnormalities.

FDA #
K233956
Product Code
DQA
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