FDA Radiology AI Devices

EdgeFlow UH10 is a handheld ultrasound device designed to noninvasively measure urine volume in the bladder. It uses deep learning AI to detect and outline the bladder in ultrasound images, calculates bladder volume, and displays results on its touchscreen. It supports both B-mode and harmonic imaging, helping healthcare professionals quickly assess bladder volume accurately and efficiently.

Overjet Caries Assist-Pediatric is an AI-powered software designed to assist dentists by automatically detecting and outlining dental caries in bitewing and periapical radiographs of pediatric patients aged 4-11. It provides additional visual cues to support clinical diagnosis but is not a replacement for the dentist's comprehensive review and judgment.

The iCAS-LV software from HighRAD Ltd. is an advanced image analysis tool that helps physicians visualize and evaluate liver lesions in CT scans. It uses interactive segmentation, automatic registration, and volume measurement to track lesions' size, shape, and changes over time, supporting clinical decision-making without replacing physician judgment.

BoneMRI is an AI-powered software that enhances MRI images to better visualize bone structures in the pelvic and spine regions. It improves the contrast of bone relative to soft tissue to assist radiologists and orthopedic surgeons in assessing bone morphology and tissue radiodensity without replacing CT imaging. It supports clinical use in patients aged 12 and older and operates via hospital networks, ensuring data security.

MAGNETOM Cima.X Fit is a magnetic resonance imaging (MRI) system by Siemens that produces detailed cross-sectional images of the body, head, or extremities. It incorporates AI-driven software features to enhance image quality and accelerate scanning, helping clinicians diagnose by providing clearer and faster MRI scans.

inHEART Models is a suite of medical imaging software tools designed to assist physicians, cardiologists, and radiologists by automatically processing CT images to create 3D models of the heart. It uses AI for automatic segmentation and visualization, helping clinicians better interpret cardiac anatomy for diagnosis and treatment planning.

CT Cardiomegaly is a command-line software tool designed to automatically measure the cardiothoracic ratio from CT chest images. It uses machine learning algorithms to segment the heart and thoracic cavity and calculate both linear and area-based cardiothoracic ratios. This assists physicians in identifying cardiomegaly, providing quantitative measurements to support clinical decisions within healthcare settings.

Overjet Charting Assist is an AI-powered medical image processing system that helps dental professionals detect and identify dental structures such as teeth anatomy and past restorative treatments on various dental radiographs. It assists in creating dental charts more efficiently by analyzing bitewing, periapical, and panoramic images, helping reduce manual charting efforts by over 80%.

The Revolution Ascend Sliding is a CT X-ray system designed to generate detailed cross-sectional images of the body, including head, whole body, cardiac, and vascular areas. Uniquely, it features a gantry mounted on a transporter allowing linear movement on rails, improving patient workflow by enabling imaging and treatment procedures in the same room without moving the patient. It supports a range of acquisition modes and image processing features to aid clinicians in diagnosis and therapy monitoring.

QOCA® image Smart RT Contouring System is an AI-powered post-processing software designed to automatically outline organs at risk on CT scans. This helps radiation oncology clinicians efficiently prepare treatment plans by providing accurate organ contours as input data for radiation therapy, improving workflow and precision in treatment delivery.