FDA Radiology AI Devices

The Geniant Cranial is a navigated neurosurgical positioning robot designed to assist neurosurgeons in accurately locating anatomical structures and guiding surgical instruments during neurosurgical procedures. It uses preoperative CT or MR images to create 3D models and tracks surgical tools in real-time, helping surgeons plan and follow surgical routes more precisely, thereby improving surgical outcomes and safety.

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.

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.

Second Opinion CC is a specialized AI software designed to assist dental professionals in identifying dental caries on bitewing and periapical radiographs. It processes dental X-ray images and highlights potential caries regions using polygonal contours, helping clinicians review images more effectively as a second reader without replacing their clinical judgment.

VIVIX-M is a series of advanced flat panel detectors designed for digital mammography. These detectors capture high-quality digital X-ray images of the breast to assist clinicians in screening and diagnosing breast conditions. The system processes the X-ray signals into detailed digital images compatible with medical imaging workflows, supporting effective and accurate mammography examinations.

Cardiac Guidance software helps medical professionals capture standard cardiac ultrasound views by providing real-time AI-powered guidance, quality feedback, and automatic image capture during echocardiography. It supports better image acquisition for accurate cardiac assessment, assisting clinicians during ultrasound exams.

The Respiration Data Management Software is a healthcare application installed on a computer that helps clinicians monitor and manage respiratory therapy treatment data from compatible CPAP and BPAP devices. It allows viewing treatment data, generating reports, and remotely adjusting therapy device settings to assist in patient care within healthcare facilities safely and efficiently.

The Ziehm Vision RFD is a mobile fluoroscopy system with a flat panel detector used to provide real-time digital imaging during diagnostic and interventional surgical procedures. It helps clinicians visualize complex anatomical structures in various body regions including the spine, joints, and cardiovascular system, aiding in procedures such as cardiology, orthopedics, neurology, and more. The device offers advanced digital subtraction and cine imaging, enhancing image quality and surgical navigation accuracy to improve clinical outcomes for patients.

The uCT 550 is a computed tomography (CT) X-ray system designed to produce detailed cross-sectional images of the whole body, including head, neck, cardiac, and vascular regions. It uses advanced AI-based deep learning algorithms to enhance image quality, reduce noise, and allow for dose reduction. This system helps clinicians with better diagnostic imaging across multiple body regions with improved accuracy and efficiency.

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.