FDA Radiology AI Devices

MRI Planner is a software tool for radiation oncologists and medical physicists that uses MRI images to help plan radiotherapy treatments. It generates synthetic CT images and automatically outlines certain healthy anatomical structures to assist in treatment planning, particularly for cancers in the brain, head-neck, and pelvic regions. This helps improve the accuracy and efficiency of radiotherapy planning without manually contouring from scratch.

AutoContour RADAC V2 is a software tool that helps radiation treatment planners by automatically outlining anatomical structures in CT and MR images to assist in radiation therapy treatment planning. It uses machine learning models trained on large datasets to generate these contours and allows clinicians to review and modify them before exporting for use in treatment.

The HS40 Diagnostic Ultrasound System by Samsung Medison is a general-purpose, mobile ultrasound device designed to acquire and display ultrasound images and analyze body fluids. It supports multiple imaging modes including 2D, 3D/4D, Doppler, and elastography, and incorporates AI-based features such as NerveTrack for nerve detection and UterineAssist for uterus segmentations to aid clinicians in diagnosis and procedural guidance.

MI View&GO is a software application developed by Siemens for medical professionals to review, manipulate, and analyze medical images from modalities like PET, SPECT, CT, and MRI. It integrates molecular imaging with anatomical data to support disease management in oncology, cardiology, neurology, and organ function, and aids in radiotherapy planning. The software enhances image processing efficiency directly at the scanner console, allowing for timely quality assessment and basic reading of images.

TeraRecon Neuro is an AI-powered image processing software that analyzes brain perfusion data from CT or MRI scans. It helps healthcare professionals visualize blood flow and other key parameters in the brain to aid diagnosis, treatment planning, and post-treatment evaluation by providing detailed parametric maps and 3D visualizations of brain tissues and vessels.

AI-Rad Companion (Pulmonary) is AI-powered software that analyzes chest CT scans to help radiologists and clinicians identify and measure lung structures and lesions. It segments lungs and lung lobes, detects lung nodules, compares current images to prior scans for lesion follow-up, and quantifies pulmonary density. These features support the clinical assessment and monitoring of lung diseases, improving workflow efficiency and diagnostic accuracy.

ClearPoint Maestro Brain Model is a software tool that uses AI to automatically identify, label, and measure the volume and shape of various brain structures from MRI scans. This helps clinicians by simplifying and speeding up the process of brain image analysis, supporting diagnosis and treatment planning in neurological conditions.

Transpara 1.7.2 is an AI-based software tool that helps radiologists detect and assess suspicious regions in breast mammography and tomosynthesis exams. It highlights potential cancerous lesions, scores their likelihood of malignancy, and provides an overall exam score to assist in clinical decision making, enhancing the accuracy and efficiency of breast cancer screening.

Customize is a prescription-use software tool designed to assist clinicians in planning ankle arthroplasty surgeries. It uses CT and X-ray images to generate 3D models and helps visualize and modify surgical treatment plans. The software incorporates AI to segment anatomical structures, improving preoperative planning and communication of treatment options.

Deep Learning Image Reconstruction by GE Healthcare is a software solution that uses a specialized deep neural network to reconstruct high-quality CT images from raw X-ray data. It produces images with less noise and improved image quality while maintaining low radiation dose. It supports head, whole body, cardiac, and vascular CT scans, helping clinicians obtain clearer images for diagnosis.