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.
510k4/4/2025
HeartFocus (V.1.1.1) is an AI-powered software accessory designed to help healthcare professionals acquire high-quality 2D cardiac ultrasound images. It guides users in real-time to position the ultrasound probe correctly and detects when images meet diagnostic quality. This assists both experienced sonographers and less trained medical professionals in capturing standardized heart views, improving the quality and consistency of cardiac ultrasound exams.
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