FDA Radiology AI Devices

Overjet Periapical Radiolucency Assist is an AI-powered software designed to help dentists detect periapical radiolucencies in dental X-ray images, specifically on periapical radiographs. It provides automated, concurrent read assistance to improve diagnostic accuracy, supporting dentists in identifying potential issues in permanent teeth for patients aged 12 and older. The tool acts as a supplementary aid, enhancing clinical decision-making without replacing professional judgment.

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.

The XIDF-AWS801 Angio Workstation (Alphenix Workstation), V9.5, by Canon Medical Systems is a medical imaging system used alongside interventional angiography equipment. It provides 2D and 3D imaging to assist clinicians in visualizing blood vessels throughout the body during catheter procedures. The device incorporates AI deep learning software to improve the detection and stabilization of stent markers, enhancing image clarity and aiding in diagnosis and treatment planning.

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.

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.

The Rapid Aneurysm Triage and Notification device by iSchemaView Inc. is an AI-powered software designed to analyze CT angiography images of the head to detect suspected saccular aneurysms. It helps hospital networks and radiologists by prioritizing cases with potential aneurysms for faster review, improving workflow in routine patient care. The software provides notifications and compressed preview images for informational use, supporting radiologists in triage but not intended for diagnosis.

Sonio Detect is a software tool that uses machine learning to help healthcare professionals during fetal ultrasound exams by automatically detecting views, anatomical structures, and verifying the quality of images in real-time. This supports sonographers and fetal specialists to ensure comprehensive and high-quality ultrasound examinations for fetuses from 11 to 37 weeks gestational age.

syngo.CT Lung CAD (Version VD30) is a computer-aided detection tool developed by Siemens Healthcare GmbH to help radiologists identify solid and subsolid pulmonary nodules in chest CT scans. The software highlights regions that might be overlooked, improving the accuracy and efficiency of lung nodule detection during radiological review. It can operate as a first or second reader and includes a mode to filter out subsolid and fully calcified nodules for focused analysis.

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.

The Voluson SWIFT and Voluson SWIFT+ are advanced diagnostic ultrasound systems used by healthcare professionals for imaging and analyzing the human body and fluids. These systems support multiple clinical applications including fetal/obstetrics, abdominal, cardiac, musculo-skeletal, and vascular imaging using various ultrasound modes such as B-mode, Doppler, 3D/4D imaging, and elastography. They feature AI-assisted tools like Auto-Caliper for improved measurement accuracy, enhancing clinicians' ability to perform exams efficiently and precisely in hospital or clinical settings.