FDA Radiology AI Devices

CephNinja is a software tool designed for dental professionals to assist in orthodontic treatment planning and case diagnosis by enabling cephalometric tracing and analysis of lateral cephalometric x-ray images. It operates on macOS and iOS platforms, supporting 2D image visualization and detailed landmark digitization but requires interpretation by trained practitioners. The software is not intended for standalone diagnostic use, especially its mobile version.

Rapid Neuro3D is an AI-powered medical software that processes CT angiography scans to provide 3D and 2D visualizations of the brain's arterial blood vessels. It helps physicians confirm the presence or absence of identified lesions and assists in evaluation and treatment planning by simplifying image interpretation.

The Nicolet EDX is a diagnostic system by Natus Neurology Incorporated that helps healthcare providers measure electrical activity in nerves and muscles through tests like nerve conduction studies, electromyography, and evoked potentials. It assists clinicians in assessing nervous system function, locating neural structures during surgery, and supporting diagnosis of neuromuscular conditions by recording and analyzing electrophysiological signals.

The Precision AI Surgical Planning System (PAI-SPS) is an AI-enhanced medical device that assists surgeons in planning and performing shoulder joint replacements. It uses CT scan images to create a 3D model of the patient's shoulder, helps surgeons simulate and optimize implant positioning, and can produce custom surgical guides for use during the procedure. This system helps improve surgical accuracy and outcomes for shoulder arthroplasty patients.

The Ziehm Vision RFD 3D is a medical imaging device that provides high-quality 2D and 3D fluoroscopic X-ray images during surgical and diagnostic procedures. It helps clinicians visualize complex anatomical structures such as bones, joints, and soft tissues in real-time, improving outcomes in orthopedic, neurological, trauma, and other surgeries. The system supports computer-assisted surgery by providing detailed imaging and C-arm positioning data, facilitating safer and more accurate interventions.

The Aurora system is a hybrid medical imaging device combining nuclear medicine (SPECT) and computed tomography (CT) technologies to help healthcare professionals detect, diagnose, and monitor diseases such as cardiovascular disorders, neurological conditions, and cancer. It enhances images using advanced acquisition, gating, and software features, improving evaluation and patient care across a variety of clinical applications.

TBS iNsight (V4) is a software tool that processes bone density images from DXA scans to calculate a Trabecular Bone Score (TBS). This score helps clinicians assess bone quality and fracture risk, complementing standard bone density measurements. The software improves the accuracy of evaluating osteoporosis and bone health, aiding in diagnosis and treatment monitoring.

Prenuvo Body Composition is an MRI-based system that analyzes the body's composition. It helps clinicians assess various tissues in the body non-invasively, supporting diagnosis and patient management in radiology.

The EVIS EUS Endoscopic Ultrasound Center Olympus EU-ME3 is a real-time endoscopic ultrasound imaging system designed to be used with Olympus ultrasound endoscopes and probes. It captures ultrasound images within various internal organs such as the gastrointestinal tract, biliary and pancreatic ducts, and others. The system supports various ultrasound modes including B mode, Doppler modes, harmonic imaging, elastography, and shear wave quantification to provide comprehensive diagnostic information, helping clinicians in diagnosis and treatment planning.

The Digital Color Doppler Ultrasound System (P60 Series) by Sonoscape Medical Corp. is an advanced ultrasound imaging instrument that uses multiple modes including color Doppler and AI-based features to help clinicians evaluate a wide range of body regions and conditions with high detail and accuracy. It supports AI-powered automatic recognition and measurement to aid in fetal ultrasound examinations and other diagnostic exams, improving workflow efficiency and diagnostic performance.