FDA Radiology AI Devices

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.

The Neu Platform is a smartphone application and clinician dashboard system designed to remotely measure and quantify tremor severity in patients aged 45 or older with mild to moderate Parkinson's Disease. It collects motion data via smartphone accelerometers, allowing patients to perform motor assessments and report symptoms remotely, while clinicians can review this data in a secure web portal to monitor and manage the patient's condition more effectively.

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.

The CLARUS 700 is an advanced ophthalmic imaging device designed to capture high-resolution images of the retina and ocular structures to aid clinicians in diagnosing and monitoring eye diseases. It supports true color, autofluorescence, fluorescein angiography, and indocyanine green angiography imaging modes over wide fields of view. The device incorporates AI algorithms for optic nerve head detection to improve image alignment and provides tools for image annotation and measurement, facilitating comprehensive eye health analysis.

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.

autoSCORE V2.0 is an AI-based software that helps medical professionals review EEG recordings by identifying and classifying sections indicating brain abnormalities such as epileptiform and non-epileptiform activities. It assists neurologists by marking likely abnormal EEG segments, providing probabilities for specific abnormality types, thereby enhancing the efficiency and accuracy of EEG interpretation without replacing clinical judgment.