FDA Radiology AI Devices

Second Opinion® Pediatric is an AI-driven software designed to assist dental clinicians in detecting caries in bitewing and periapical radiographs of patients aged 4 years and older. It uses machine learning to identify and visually overlay potential caries lesions on dental X-rays, helping clinicians with improved detection accuracy without replacing professional judgment.

Vscan Air is a pocket-sized, battery-operated ultrasound imaging system designed for use by trained healthcare professionals. It operates wirelessly with a mobile app and provides ultrasound images and measurements across many clinical areas including abdominal, cardiac, obstetrics, musculoskeletal, and vascular applications. The device incorporates AI features to enhance diagnostic accuracy and assist clinicians, such as automatic bladder volume measurement using deep learning, and real-time guidance for cardiac imaging.

The Flash Ultrasound System 5100 Point of Care by Philips Ultrasound LLC is a diagnostic ultrasound system designed for point-of-care use. It offers multimodal ultrasound imaging including B-mode, Doppler, and M-mode for a wide range of anatomical regions and clinical settings, enabling clinicians to perform fluid flow analysis and image diagnostics efficiently in environments like hospitals, emergency rooms, and outpatient clinics. This system helps healthcare professionals make faster and well-informed clinical decisions using advanced ultrasound technology in a compact and user-friendly device.

Kosmos by EchoNous, Inc. is an imaging system that uses pulsed Doppler ultrasound technology to assist radiology professionals in medical imaging. It helps clinicians by providing detailed ultrasound images for diagnostic purposes involving blood flow and tissue imaging.

Lung AI (LAI001) is a software tool that assists healthcare professionals by analyzing lung ultrasound scans to detect signs of consolidation/atelectasis and pleural effusion. It highlights regions of interest on ultrasound cine clips to help clinicians identify potential lung issues, improving review efficiency but not replacing clinical judgment or other diagnostic tests. It supports physicians particularly in emergency departments during point-of-care lung ultrasounds.

Second Opinion Periapical Radiolucency Contours is an AI-based computer-aided detection software that helps dentists identify areas of periapical radiolucency in dental X-rays by outlining suspected regions with polygonal contours. It supports dental professionals by providing a second opinion when reviewing periapical radiographs, potentially improving detection accuracy and aiding clinical decisions.

Oncospace is a software tool designed to help radiation oncologists and dosimetrists plan cancer treatments more efficiently. It uses machine learning to predict dose objectives for organs at risk based on patient anatomy, assists in setting up treatment protocols, and integrates with treatment planning systems to optimize and review radiotherapy plans. This helps clinicians design safer and more effective radiation schedules for patients with cancers in various body regions.

cmAngio® (V1.6) is an AI-based software product designed to assist radiologists by automatically processing radiological images, potentially helping to detect or analyze vascular conditions.

syngo.CT LVO Detection is an AI-powered post-processing software that analyzes CT angiography images of the brain to help clinicians prioritize cases by detecting suspected large vessel occlusions in specific brain vessels. It aids in triage but is not used for standalone diagnosis or altering images, thereby assisting medical professionals in managing stroke patients more efficiently.

HeartFocus (V.1.1.1) is an AI-powered software accessory designed to help healthcare professionals acquire high-quality 2D cardiac ultrasound images. It guides users in real-time to position the ultrasound probe correctly and detects when images meet diagnostic quality. This assists both experienced sonographers and less trained medical professionals in capturing standardized heart views, improving the quality and consistency of cardiac ultrasound exams.