FDA Radiology AI Devices

QuickRad is a web-based PACS (Picture Archiving and Communication System) designed for radiology centers and hospitals. It manages and displays medical images from various scanners including CT, MRI, ultrasound, and X-ray, and allows users to integrate FDA-cleared AI models to assist radiologists by visualizing AI outputs alongside images. This helps clinicians by improving workflow efficiency and providing advanced image viewing and reporting tools.

ScanDiags Ortho L-Spine MR-Q is an AI-powered software tool that processes previously acquired lumbar spine MRI images to provide quantitative measurements of spinal anatomical structures such as vertebral bodies, intervertebral discs, neuroforamina, and thecal sacs. It utilizes deep learning algorithms for semi-automatic segmentation and measurements, allowing radiologists to review and adjust results. This tool helps clinicians save time and improve the accuracy of lumbar spine assessment without replacing their expert interpretation.

Sonio Suspect is a cloud-based AI software designed to assist clinicians during or after fetal ultrasound examinations by automatically detecting and characterizing abnormal fetal findings. It helps healthcare professionals identify potential issues in fetal development, improving diagnostic accuracy and supporting better patient management decisions.

The Acclarix AX8 and AX9 Series Diagnostic Ultrasound Systems by Edan Instruments are advanced ultrasound imaging devices used by clinicians for a wide range of clinical applications including abdominal, cardiac, musculoskeletal, and vascular imaging among others. These systems support multiple imaging modes such as B mode, Doppler, harmonic imaging, elastography, and contrast imaging, aiding healthcare professionals in acquiring and interpreting ultrasound data to diagnose and monitor patient conditions effectively.

CaRi-Plaque is a web-based software application that aids trained medical professionals by automatically analyzing cardiac CT scans to quantify and characterize coronary artery plaques and stenoses. It provides detailed measurements on plaque volumes and vessel stenosis to help clinicians assess coronary artery disease and guide treatment decisions, complementing their clinical judgment.

The EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is software that assists medical professionals by automatically analyzing chest X-ray images to detect misplaced endotracheal tubes. It uses deep learning to flag suspicious cases and prioritize them in the workflow, helping radiologists review these urgent cases more quickly. The software provides alerts when the tube tip is positioned too high, too low, or incorrectly and supports clinical decision-making by improving triage efficiency.

The NUSONO Handheld Ultrasound Scanner is a portable, software-driven ultrasound imaging system that interfaces wirelessly with mobile devices to provide high-resolution diagnostic imaging in various clinical applications. It supports multiple imaging modes, including B-mode, M-mode, Color Doppler, and Power Doppler, enabling healthcare professionals to effectively diagnose conditions across fetal, abdominal, pediatric, urology, gynecology, cardiac, and lung areas. By integrating with smartphones and tablets, it offers flexible, real-time imaging solutions for use in clinics, hospitals, and point-of-care settings, enhancing diagnostic confidence and accessibility.

Brainomix 360 e-Lung is a software tool designed to assist physicians by providing automated, quantitative analysis of chest CT images. It offers 3D segmentation, volumetric measurements, and density evaluations of lung tissue to support diagnosis and longitudinal assessment of lung diseases, enhancing workflow efficiency and accuracy in radiological interpretation of CT thoracic scans.

The OPTOVISION Endoscopic Light Source Unit by Optosurgical LLC is a device designed to provide real-time visible and near-infrared fluorescence imaging during endoscopic procedures. Using indocyanine green (ICG) dye, it helps surgeons visualize vessels, blood flow, tissue perfusion, lymphatic systems, and bile ducts to aid minimally invasive surgeries, improving surgical precision and patient outcomes.

AVIEW CAC is a software tool designed for healthcare professionals to analyze non-contrast, non-gated Chest CT scans and quantitatively evaluate calcified plaques in coronary arteries. It automatically calculates the Agatston score, segments and evaluates the coronary arteries, and provides risk stratification based on calcium score, gender, and age. It facilitates access to CT data on various platforms, helping clinicians assess coronary artery disease risk using existing CT images.