FDA Radiology AI Devices

The Lux HD 2530 detector is a digital flat panel X-ray imager used in radiology to capture high-quality X-ray images. It helps clinicians obtain detailed radiographic images for diagnosis and treatment planning with improved image quality over traditional detectors.

The EMBOTRAP III Revascularization Device is a specialized catheter used to remove blood clots from vessels in the brain, helping to restore blood flow in patients with ischemic stroke. It assists clinicians in performing minimally invasive procedures that can improve outcomes for stroke patients by clearing vessel blockages.

The Digital X-Ray DentiMax Pro Imaging System is an advanced digital extraoral X-ray imaging device used primarily in dental radiology. It helps dentists capture high-quality images of the oral and maxillofacial region to assist in diagnosis and treatment planning.

The uDR Aurora CX is a stationary X-Ray system designed for radiology applications. It helps clinicians obtain high-quality X-Ray images which can be used for diagnostic purposes, potentially supporting AI tools in image analysis and patient care.

The BONX805 is a mobile X-ray system designed for radiology applications. It helps clinicians by providing portable X-ray imaging capabilities, facilitating diagnostic imaging in various clinical settings where mobility is essential.

The device is a dental X-ray system designed to capture extraoral images of patients' teeth and jaws. It assists clinicians in diagnosing dental conditions by providing clear X-ray images, potentially enhanced or interpreted with AI technologies to improve diagnostic accuracy and workflow.

OsteoSight™ Hip (v1) is a radiology software designed to opportunistically evaluate low bone mineral density from medical images, helping clinicians identify patients at risk for osteoporosis and related fractures.

Definium Tempo Select is a stationary X-Ray system developed by GE Hualun Medical Systems. It provides high-quality X-Ray images to help clinicians diagnose and assess various medical conditions through radiologic imaging.

PROMO is a mobile X-ray system designed for use in radiology to capture diagnostic images. This device helps clinicians by enabling flexible and convenient imaging at the point of care, potentially integrating AI for image processing or analysis to support clinical decisions.

VEA Align; spineEOS by EOS imaging is an AI-based software designed to automatically process radiological images of the spine. It helps clinicians by aligning and analyzing spinal images, improving accuracy and efficiency in diagnosing and treatment planning for spinal conditions.