FDA Radiology AI Devices

Lung-CAD is an AI-powered software that helps physicians by analyzing chest X-rays to identify areas showing interstitial thickening. It highlights these areas with bounding boxes, serving as a concurrent reading aid to improve detection. It does not replace physicians but supports them in interpreting lung images more effectively in adults.

DeepXray is an AI-powered software that helps medical professionals analyze knee X-rays by automatically measuring joint space width and assessing signs of osteoarthritis such as sclerosis, joint space narrowing, and osteophytes. It supports clinicians by providing detailed grading based on established radiographic criteria and offers an interactive report for review and editing before finalizing.

qXR-PTX-PE is an AI-powered software that assists radiologists by automatically analyzing adult chest X-rays to detect signs of pleural effusion and pneumothorax. It helps prioritize cases by providing case-level outputs within the existing PACS/workstation without altering images or providing direct clinical diagnosis, thereby improving workflow efficiency.

VisiRad XR is an AI-powered software that helps physicians detect suspicious lung nodules and masses on chest X-rays by marking regions of interest. It acts as a second reader to assist radiologists in their interpretations, enhancing diagnostic accuracy for adult patients in outpatient or emergency settings.

Spine CAMP™ (1.1) is an automated software that analyzes X-ray images of the lumbar and cervical spine to generate measurements and visualizations of spinal alignment, stability, degeneration, and motion. It supports healthcare professionals in clinical decisions related to spinal health by producing detailed reports from radiographic data.

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.

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.

Annalise Enterprise CXR Triage Trauma is an artificial intelligence-based software that assists clinicians by automatically analyzing adult chest X-rays to identify signs of pleural effusion and pneumoperitoneum. It integrates with hospital imaging systems to prioritize urgent cases in the clinical workflow, helping healthcare providers quickly identify critical findings and streamline patient care.

Annalise Enterprise CXR Triage Trauma is an AI-based software tool designed to assist clinicians by analyzing adult chest X-ray images to detect features suggestive of vertebral compression fractures. It integrates with hospital image and order management systems to prioritize cases with potential fractures, facilitating timely review in clinical workflows such as Bone Health and Fracture Liaison Service programs. The device supports clinicians in identifying urgent cases but does not replace clinical decision-making.