FDA Radiology AI Devices

The Azurion R3.1 by Philips Medical Systems B.V. is an interventional fluoroscopic X-ray system designed for use in radiology. It aids clinicians by providing real-time X-ray imaging to guide minimally invasive procedures, enhancing the accuracy and safety of interventions.

The Cocoon Solo (DX-7020s) is a digital extraoral X-ray system used in radiology to capture high-quality images, assisting clinicians in dental and maxillofacial diagnosis and treatment planning.

The Mobile X-ray unit (!M1) is a portable X-ray system designed to capture radiographic images outside of traditional imaging suites, providing flexibility for bedside or remote patient imaging. It assists clinicians by enabling quick and accessible diagnostic imaging, potentially integrating with AI tools for enhanced image analysis and diagnosis.

Syngo Carbon Clinicals (VA41) is an automated software solution by Siemens Healthineers designed to assist radiologists by processing radiological images, improving workflow and aiding in diagnostic efficiency.

TeraRecon Cardiovascular.Calcification.CT is an AI-powered software that analyzes CT images to automatically detect and measure calcifications in the cardiovascular system, helping clinicians assess cardiovascular health and risks more efficiently.

ANDI 2.0 is an AI-based software tool designed to automatically process radiological images. It helps clinicians by enhancing image analysis, potentially improving diagnostic accuracy and efficiency.

Sirona Advanced Imaging Suite is an image processing system designed for radiological applications. It helps clinicians by enhancing and analyzing medical images to support diagnosis and treatment planning.

The XC11 ICE System by Yorlabs is an intravascular ultrasound catheter system used in cardiovascular imaging. It helps clinicians visualize inside blood vessels to assess heart conditions and guide interventions.

The X1-FFR by SpectraWAVE, Inc. is a software tool that uses X-ray angiographic images to simulate coronary vascular conditions, helping clinicians assess coronary artery disease noninvasively.

The INDIGO® Aspiration System uses special aspiration tubing to help remove blood clots from peripheral blood vessels. This system assists clinicians in mechanical thrombectomy procedures guided by imaging, helping to restore blood flow and improve patient outcomes in vascular blockages.