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 LungVision System is a medical imaging software that helps doctors navigate tools inside the lungs during procedures. It works by segmenting CT scan data and overlaying it on live X-ray images to guide catheter placement accurately, improving procedural safety and effectiveness.

FDA #
K163622
Product Code
LLZ

Cydar EV is a cloud-based software that enhances live X-ray fluoroscopy images by overlaying 3D vessel anatomy from preoperative CT scans. This helps clinicians during endovascular procedures by improving guidance for positioning devices like guidewires and catheters, especially in the abdomen, pelvis, and lower thorax.

FDA #
K160088
Product Code
OWB
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