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 Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter is a medical imaging device designed to provide high-resolution, real-time images of coronary arteries in patients undergoing transluminal interventional procedures. It uses near-infrared light delivered via a fiber-optic catheter to visualize coronary tissue, aiding clinicians in diagnosis and treatment planning.

FDA #
K242966
Product Code
DQO
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