FDA Radiology AI Devices

VisAble.IO is a software tool that helps physicians plan and evaluate liver ablation treatments by processing CT and MRI images. It assists in identifying treatment targets, planning needle placement virtually, and confirming the treatment area post-procedure to improve procedure accuracy and patient outcomes.

AI-Rad Companion Organs RT is an AI-powered medical imaging software designed to automatically segment organs from CT and MR scans to assist radiation therapy treatment planning. It uses deep learning algorithms to produce contours of organs-at-risk, which clinicians can review and edit before using them in treatment planning systems. This software saves time and improves the accuracy of radiation therapy preparation by providing automated organ delineation, intended for use by trained medical professionals.

AI-Rad Companion (Pulmonary) by Siemens Healthcare GmbH is software that uses machine learning and deep learning to analyze previously acquired chest CT scans. It helps radiologists and physicians segment lungs and lung lobes, identify and measure solid and sub-solid lung nodules, and track changes over time. This supports clinicians in assessing lung diseases, improving workflow efficiency and diagnostic accuracy.

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.

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.

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.

The X-Guide Surgical Navigation System is an advanced computer-assisted navigation tool designed to assist dental surgeons during preoperative planning and intraoperative guidance of dental implants and endodontic access procedures. It integrates machine learning software to automatically process CT and intraoral scan images to segment anatomical structures and enhance surgical precision, improving patient safety and surgical outcomes.

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.

HealthFLD is an AI-powered software that analyzes CT images of the liver to provide clinicians with quantitative and qualitative measurements of liver attenuation, aiding the assessment of fatty liver disease. It processes both non-contrast and contrast CT scans for adult patients and outputs liver density metrics to support clinical decision-making.

Viz HDS by Viz.ai is an AI-powered software that automatically labels, visualizes, and measures critical brain structures such as intracranial hyperdensities, lateral ventricles, and midline shift on non-contrast head CT scans. This automation helps radiologists quickly and accurately assess brain abnormalities by providing detailed volumetric data and annotated images, improving workflow and diagnostic efficiency.