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.

RTM Sense is a wearable respiratory monitoring system that continuously tracks breathing in adult patients by analyzing sounds from airflow in the trachea. It wirelessly transmits data to a tablet, where a proprietary software algorithm analyzes and displays respiratory rate, helping clinicians monitor breathing as an adjunct to other clinical information.

FDA #
K243183
Product Code
BZQ

Philips VSC-MEDlib is a software library intended to automatically and contactlessly measure respiration rate by analyzing video streams of a patient's torso during virtual consults or health screenings. It uses camera-captured images to detect torso motion and calculate breathing frequency, providing clinicians with an additional vital sign measurement to support patient assessment. It is designed for use in clinical or home environments under healthcare professional supervision.

FDA #
K242001
Product Code
BZQ
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