FDA Radiology AI Devices

The CS-series-FP Radiographic / Fluoroscopic System with the optional CA-100S / FluoroShield ROI Assembly is an advanced fluoroscopic X-ray system that automatically manages and reduces radiation exposure by focusing on a configurable region of interest (ROI) during imaging. It blends high-resolution live imaging of the ROI with lower-exposure peripheral imaging, thus improving image quality and reducing unnecessary radiation dose to both patients and medical staff during interventional procedures.

ProFound AI Software V2.1 is an AI-based software designed to assist radiologists in detecting soft tissue densities and calcifications in 3D digital breast tomosynthesis images. It highlights suspicious breast lesions by marking areas in the images and assigns confidence scores to help physicians identify likely malignant regions, supporting earlier and more accurate breast cancer diagnosis.

Syngo.Via RT Image Suite is a software tool designed to help clinicians visualize, manipulate, and contour medical images from various imaging modalities such as CT, MRI, and PET. It supports 3D and 4D image visualization and assists with the segmentation of tumors and organs-at-risk to aid in radiation therapy planning and response assessment. The software incorporates AI techniques, including deep learning-based contouring, to improve the accuracy and efficiency of treatment preparation, thereby enhancing patient care in radiation therapy.

SubtleMR is a software device that enhances MRI images by reducing noise or increasing image sharpness using a convolutional neural network algorithm. It supports MR images from 1.2, 1.5, and 3 Tesla scanners and helps radiologists by improving image quality without requiring a user interface. This enhancement assists clinicians in better visualization of anatomical details for diagnosis and treatment planning.

SIS Software Version 3.6.0 is an advanced medical imaging application designed to assist neurosurgeons, neurologists, and radiologists by processing MRI and CT scans to create detailed 3D models of brain structures, particularly the subthalamic nuclei. It uses machine learning to enhance images, aiding in the visualization and planning of stereotactic brain surgeries, thereby improving surgical accuracy and patient outcomes.

BrainScope TBI is a portable, non-invasive device that assists clinicians in evaluating patients with mild traumatic brain injury and concussion by analyzing brain electrical activity through EEG along with cognitive tests and clinical symptoms. It helps identify the likelihood of structural brain injury and assesses brain function, supporting decisions about the need for further imaging like CT scans.

AI-Rad Companion (Cardiovascular) is an AI-powered software that analyzes previously acquired CT chest images to segment the heart and aorta, quantify coronary calcium, and measure aortic diameters. It assists clinicians by providing quantitative and qualitative cardiovascular assessments to support diagnosis and evaluation in emergency, specialty, and general practice care.

D2P is a software tool developed by 3D Systems that processes medical imaging data (DICOM) to create 3D segmentations and physical models. It assists clinicians in surgical planning by allowing the generation of accurate physical replicas of anatomical regions from imaging data, supporting diagnosis and treatment decisions in cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and musculoskeletal areas.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system that connects wirelessly to iOS or Android devices to provide high-resolution, real-time diagnostic ultrasound and Doppler imaging. It supports multiple clinical applications such as abdominal, cardiac, musculoskeletal, fetal, and procedural guidance, helping clinicians perform ultrasound imaging conveniently in diverse healthcare settings.

The Zio XT and Zio AT ECG Monitoring Systems by iRhythm Technologies, Inc. analyze continuous ECG data collected via wearable patches and generate detailed reports on cardiac events. These systems help clinicians diagnose heart rhythm abnormalities by providing comprehensive, beat-to-beat ECG analysis over long monitoring periods for patients with or without symptoms.