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.

AeviceMD is a wearable, non-invasive electronic stethoscope that records lung sounds from pediatric patients. It stores these sound recordings securely on a cloud platform, allowing healthcare professionals to later review, compare, and analyze them to support clinical assessments. The system includes hardware sensors, docking station, mobile and web apps, and cloud analytics to facilitate longitudinal monitoring of lung sound data.

FDA #
K243603
Product Code
DSH

The AT-Patch (ATP-C130/ATP-C70) is a wearable ECG monitoring device that records cardiac electrical activity for up to 14 or 7 days respectively. It collects ECG data from a patch worn on the patient's torso, which is then analyzed by software algorithms to detect arrhythmias and other cardiac events. A physician reviews this analysis to provide a report to help clinicians diagnose heart conditions, aiding in the management of symptoms like palpitations, dizziness, and fatigue.

FDA #
K242583
Product Code
DSH

The Peerbridge Cor System is a wearable ECG monitoring device designed for continuous recording and transmission of heart electrical activity over 24 hours to 7 days. It helps clinicians monitor patients with symptoms like palpitations or dizziness by generating ECG reports based on FDA-cleared algorithms, aiding clinical diagnosis.

FDA #
K171936
Product Code
DSH
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