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 Orthoscan TAU Mini C-Arm is a mobile fluoroscopic X-ray machine that provides real-time moving X-ray images. It helps clinicians with imaging during procedures, allowing better visualization and guidance for interventions.

FDA #
K250587
Product Code
OXO

The Orthoscan VERSA Mini C-Arm is a mobile fluoroscopic X-ray system designed to provide real-time imaging for diagnostic, surgical, and emergency procedures, particularly focused on limbs, extremities, and shoulders. The system enhances clinical workflow by delivering high-quality fluoroscopic images with improved ergonomics and efficiency, helping clinicians to visualize anatomy during treatment.

FDA #
K243452
Product Code
OXO

The OEC One ASD is a mobile C-arm X-ray system designed to provide fluoroscopic and digital spot images during diagnostic, interventional, and surgical procedures across various clinical specialties. It helps clinicians visualize patient anatomy in real-time to aid procedure guidance and decision making. The device uses advanced flat panel detector technology to enhance image quality and supports ease of use with features such as a touchscreen monitor, integrated printer shelf, and improved software architecture.

FDA #
K240828
Product Code
OXO
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