FDA Radiology AI Devices

GBrain MRI by Galileo CDS, Inc is an AI-powered software designed to process MRI images automatically, helping radiologists interpret brain scans more efficiently.

EchoPAC Software is a tool developed by GE Medical Systems that processes ultrasound images to assist clinicians in analyzing echocardiography data. It helps in improving workflow efficiency and accuracy in cardiac ultrasound interpretation.

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.

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.

Clever One is dental imaging software designed to acquire, process, view, and analyze 2D and 3D medical images from dental CT, panoramic, cephalometric, and intraoral imaging devices. It helps clinicians by providing advanced visualization and analytic tools such as bone density analysis, implant planning, and multi-planar reconstructions, facilitating more accurate diagnostics and treatment plans.

The UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program by Canon Medical Systems Corporation is software designed to help physicians analyze and observe images from ultrasound examinations. It supports data from specific diagnostic ultrasound systems and includes AI-enabled features for advanced cardiac motion tracking and measurement, aiding clinical decision-making in hospital and clinical settings.

SubtleHD (1.x) is an AI-based image processing software designed to enhance MRI images from any body part. It improves image quality by reducing noise and increasing sharpness, helping radiologists obtain clearer images without changing the original scan process. This facilitates improved diagnostic confidence and visualization of anatomical structures.

Ezra Flash is a software device that improves the quality of MRI images of the head, abdomen, and pelvis by reducing noise using advanced neural network algorithms. It processes images from 1.5T and 3T Siemens and GE MRI scanners, helping clinicians get clearer images to support more accurate diagnoses without additional scanning time.

The OrthoNext Platform System is a web-based software that helps healthcare professionals plan orthopedic surgeries and treatments by overlaying product templates on X-ray images and providing measurement and simulation tools. It assists in both preoperative and postoperative planning, enabling clinicians to make informed decisions by digitally visualizing and measuring treatment options.

Overjet Image Enhancement Assist is a software tool that improves the quality of dental x-ray images such as bitewing, periapical, and panoramic images. It uses AI algorithms to reduce noise and enhance contrast and sharpness, helping dental professionals see clearer images for better diagnosis. The software operates within the Overjet device platform and is intended to be an optional enhancement tool, not a replacement for existing imaging systems.