FDA Radiology AI Devices

syngo.CT Extended Functionality is a software package that provides advanced visualization and measurement tools for medical images acquired from CT and potentially other modalities like MRI. It helps technicians and physicians perform qualitative and quantitative analysis of clinical imaging data to assist in diagnosis by creating detailed images and measurements using various specialized extensions.

CoLumbo is a medical imaging AI software tool designed to assist radiologists and spine surgeons by automatically segmenting and measuring lumbar spine features from MRI images. It highlights out-of-range measurements and generates reports for review and approval by clinicians, improving the efficiency and consistency of lumbar spine evaluation, but does not provide diagnosis.

ElucidVivo A.3 is a medical image analysis software that processes and visualizes CT angiographic images to help physicians assess arterial vessels and stratify patients with atherosclerosis. It offers tools for measurement and visualization of vessel structure and plaque characteristics, supporting clinical decision-making without providing direct diagnosis.

ART-Plan is an advanced software tool designed to assist medical professionals in cancer radiotherapy planning. It supports visualization and manipulation of 3D multi-modal medical images (CT, MR, PET-CT, CBCT, 4D-CT) and includes AI-driven automatic and semi-automatic segmentation of organs at risk and lymph nodes. It also allows image registration and generation of synthetic CT images from MRI, facilitating precise and efficient radiation treatment planning.

Quantib Prostate is an AI-powered image post-processing software designed to assist medical professionals in analyzing prostate MRI scans. It provides tools for visualization, semi-automatic segmentation of prostate anatomy and lesions, volume computations, and PI-RADS scoring support to facilitate the interpretation of prostate MR studies, aiding clinical decision-making.

The Versana Balance by GE Medical Systems is a general-purpose diagnostic ultrasound system intended for use by trained healthcare professionals. It offers various imaging modes including B-mode, Doppler, 3D/4D imaging, and elastography. The device assists clinicians by providing high-quality ultrasound images and includes AI features such as Whizz Label for anatomy identification, helping in image interpretation and workflow efficiency. It is designed for use in hospitals and clinics across a broad range of clinical applications including abdominal, cardiac, obstetrics, gynecology, vascular and musculoskeletal imaging.

Segment 3DPrint is a medical software developed by Medviso AB that helps clinicians review and segment images from medical scanners to generate detailed 3D models. These models assist doctors with visualization, measuring, and treatment planning, particularly in orthopaedic, maxillofacial, and cardiovascular fields. The software also supports creating physical 3D printed replicas from these models, enhancing clinical workflows and patient care.

MVision AI Segmentation is a software device designed to automatically create segmentation templates of anatomical regions on CT images to assist clinicians in radiation therapy treatment planning. It uses machine learning-based algorithms to generate initial contours for multiple anatomical sites, which clinicians can review and modify before use, helping to save time and improve efficiency in clinical workflows.

aPROMISE X is a software platform for healthcare professionals and researchers that assists in accepting, transferring, storing, manipulating, quantifying, and reporting digital medical images from PSMA PET/CT scans. It allows users to visualize multiple scans, mark regions of interest, and perform quantitative analysis to help identify suspicious lesions in oncology cases, improving clinical efficiency and consistency.

The EFAI RTSuite CT HN-Segmentation System is AI-powered software designed to assist radiation oncology professionals by automatically contouring organs at risk in head and neck CT images. It helps streamline radiation therapy treatment planning by providing initial segmentations that clinicians review and edit, improving workflow efficiency and accuracy.