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 FlowTriever2 Catheter is a medical device designed for the non-surgical removal of blood clots (emboli and thrombi) from peripheral blood vessels, particularly for the treatment of pulmonary embolism. It uses fluoroscopic visualization aided by radiopaque markers to guide the device through blood vessels, capturing and extracting clots to restore normal blood flow. This device helps clinicians perform thrombectomy procedures with precision, facilitating minimally invasive treatment of embolic conditions in peripheral and pulmonary vasculature.

FDA #
K250088
Product Code
QEW

The Artix™ MT and Artix™ Thin-Walled Thrombectomy Sheath are devices designed to remove clots non-surgically from peripheral blood vessels. They facilitate catheter insertion and vascular access, allowing for mechanical thrombectomy and thrombus aspiration, which assists clinicians in restoring blood flow during vascular interventions.

FDA #
K241894
Product Code
QEW
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