FDA Radiology AI Devices

IB Lab LAMA is a software tool that automatically analyzes full leg X-rays to measure discrepancies in limb length and assess knee alignment. It uses AI deep learning technology to provide precise geometric measurements to assist healthcare professionals in evaluating leg deformities and alignment issues, thereby supporting diagnosis and treatment planning.

Critical Care Suite with Pneumothorax Detection AI Algorithm by GE Medical Systems is an AI-based software tool that analyzes frontal chest X-rays to detect pneumothorax. It highlights areas of concern and provides a confidence score, helping radiologists and licensed healthcare professionals prioritize cases and accurately diagnose pneumothoraces more efficiently. The software can be integrated with existing PACS and X-ray imaging systems to streamline workflow.

Genius AI Detection 2.0 with CC-MLO Correlation is an AI-powered software designed to assist radiologists by analyzing digital breast tomosynthesis images to detect and mark suspicious soft tissue densities and calcifications. It provides confidence scores for each detected lesion, helping clinicians interpret breast cancer screening exams more effectively, including correlation between different standard mammographic views for better diagnosis workflow.

The Radiation Planning Assistant (RPA) is a web-based software tool designed to automate and assist in planning radiation therapy for cancers of the head and neck, cervix, breast, and brain metastases. It uses CT images to create contours and treatment plans with photon beam irradiation, improving efficiency and precision in radiotherapy treatment planning. The system generates outlines of organs and tumors and proposes radiation dose plans, which clinicians then review and adjust in their own treatment planning systems before use.

The Lumify Diagnostic Ultrasound System by Philips Ultrasound is a transportable ultrasound device that provides high-resolution diagnostic imaging across various modes including B-mode, Doppler, and M-mode. It incorporates an AI-based software feature that automatically detects and quantifies lung B-lines and merged B-lines from ultrasound videos to assist clinicians in assessing lung conditions such as pneumonia and pulmonary edema. The system supports multiple transducers and is designed for use by healthcare professionals in diverse clinical settings.

The iCAC Device is a software tool that analyzes routine chest CT scans to automatically detect and quantify coronary artery calcium, which helps physicians assess cardiovascular risk. It provides outputs such as calcium segmentation visualizations and quantitative calcium scores during standard clinical workflows, assisting physicians without replacing original reports or scans.

The Butterfly iQ/iQ+ Ultrasound System is a portable, handheld ultrasound device that helps healthcare professionals visualize and measure anatomical structures and fluids in both adult and pediatric patients. It supports multiple clinical applications including lung, cardiac, abdominal, and musculoskeletal imaging. The system integrates AI-powered software called Auto B-line Counter that automatically detects and counts B-lines in lung ultrasound images, aiding clinicians in diagnosing and monitoring lung conditions.

DTX Studio Clinic 3.0 is an AI-powered software tool designed to assist dentists in detecting dental conditions such as caries, bone loss, periapical radiolucency, root canal filling deficiencies, discrepancy at the margin of restorations, and calculus from intraoral radiographs. It supports review of bitewing and periapical radiographs in patients aged 15 and older, providing highlighted areas of suspicion to aid clinical assessment and diagnosis.

RadioLens v1.0 by Synapsica is a medical image management and processing system that allows radiologists and medical practitioners to view, analyze, and report on DICOM-format radiology images. The software includes an AI module called SpindleX for automated analysis and measurement of spinal ligament injuries in digital stress X-rays of the cervical and lumbar spine. This helps clinicians by providing quantitative measurements and detailed reports, enhancing diagnostic accuracy and efficiency in spinal injury assessment.

Overjet Caries Assist is an AI-powered software that helps dentists detect and segment dental caries (tooth decay) on bitewing and periapical X-ray images. It provides computer-generated annotations highlighting potential caries to support dentists' diagnosis, improving sensitivity in caries detection. It operates by processing dental radiographs using machine learning models and presenting annotated images in a viewer interface for the dentist. This assists dentists but does not replace professional judgment.