FDA Radiology AI Devices

TumorSight Viz is an automated radiological image processing software designed to assist clinicians by analyzing medical images for tumor-related information, potentially improving diagnosis and treatment planning for patients with tumors.

The syngo.via MI Workflows, including Scenium and syngo MBF, are Siemens software tools designed to assist radiologists by automating the processing of medical images, improving workflow efficiency and potentially supporting diagnosis through advanced image analysis.

Bunkerhill Abdominal Aortic Quantification (AAQ) is AI software designed to analyze radiological images to quantify the abdominal aorta. This helps clinicians assess and monitor conditions related to the abdominal aorta more efficiently and accurately.

PIUR tUS inside is a medical device that enhances standard 2D ultrasound devices by generating three-dimensional (3D) tomographic ultrasound volumes of the thyroid. It assists physicians in diagnosing thyroid nodules by providing volumetric information, segmentation, and quantification of sonographic characteristics. This device operates directly on compatible ultrasound scanners, integrating sensor data to create 3D images that support clinical decision-making as an add-on to regular ultrasound imaging.

Synapse PACS (7.5) by FUJIFILM Healthcare Americas Corporation is a web-based software application designed to manage, display, and process medical images from various modalities. It provides advanced tools such as measurements, regional segmentation, 3D volume rendering, fusion, and structured report generation to support clinicians like radiologists and cardiologists in reading, interpreting, and planning patient care efficiently.

EchoConfidence (USA) is an AI-powered software that helps clinicians analyze transthoracic echocardiogram images. It automatically classifies views, segments cardiac structures, measures cardiac function, and performs Doppler assessments, improving the efficiency and accuracy of cardiac image interpretation for adults and adolescents.

Brainlab Elements (7.0) is a suite of medical imaging software applications that aid clinicians in planning cranial and extracranial surgical and radiotherapy treatments. It provides tools for image fusion (aligning different imaging datasets), angiographic image registration, contouring (outlining anatomical structures), fibertracking (visualizing brain white matter tracts from diffusion imaging), and functional MRI mapping. The device supports precise treatment planning by combining and analyzing various imaging data, helping clinicians visualize critical anatomical and functional areas without being used for diagnostic purposes.

Viz Subdural+ is an AI-powered software that automatically analyzes head CT scans to measure subdural collections and midline shift. It helps clinicians by providing automated volume and width measurements of subdural collections, improving efficiency and accuracy in brain injury assessment.

Cirrus Resting State fMRI Software is a medical imaging software that processes resting state functional MRI data to generate brain maps showing motor, language, and vision networks. These maps assist clinicians such as surgeons and radiologists in visualizing functional areas of the brain non-invasively, aiding in pre-surgical planning and clinical decision-making.

BrightHeart View Classifier is a cloud-based AI-powered software designed to analyze 2D fetal ultrasound images and video clips to automatically identify and classify standard fetal heart views. It assists trained healthcare professionals in acquiring and interpreting fetal heart ultrasound exams in the second and third trimesters by providing annotated outputs and validating whether scanning protocols are met, improving diagnostic workflow and consistency.