FDA Radiology AI Devices

MEDIP PRO is a medical imaging software that helps clinicians by processing CT and MRI images. It provides tools for segmenting images, improving image quality, and creating 3D reconstructions that can be exported for 3D printing to aid in preoperative planning. The software is intended to be used alongside other diagnostic tools and clinical judgement to support treatment planning.

Merge PACS is a software system that helps medical professionals view, analyze, and manage images from various medical imaging modalities such as CT, MRI, PET, ultrasound, and mammography. It supports diagnostic reading, reporting, and communication workflows, enabling clinicians to efficiently handle patient imaging studies and related data. It includes advanced image manipulation tools and workflow management features to assist radiologists and other medical staff.

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.

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.

SurgicalAR is a software platform that allows clinicians to view and manipulate medical images in both traditional 2D and advanced 3D formats, including augmented reality via head-mounted displays. It aids surgical planning and medical image review by providing tools such as image manipulation, measurements, and 3D visualization of CT and MR images. This enhances the understanding of complex anatomical structures to improve clinical decision making.

AI Rad Companion (Engine) by Siemens Medical Solutions is a software platform designed to assist technicians and physicians in viewing, processing, and analyzing medical images from multiple modalities. It supports integration with PACS systems and allows external AI-based post-processing extensions, improving clinical image analysis and workflow.

Centricity Universal Viewer by GE Healthcare is a medical imaging software solution designed to display, manage, analyze, and share medical images from multiple imaging modalities. It facilitates radiologists and cardiologists in interpreting diagnostic images, improving workflow and clinical decision-making. It supports many imaging formats but is not intended for digital pathology diagnosis. The product enhances clinicians' ability to view and interpret images efficiently across healthcare systems.

icobrain is an AI-powered software that automates the identification, labeling, and volume measurement of brain structures from MR and CT images. It assists clinicians in evaluating brain conditions such as dementia and traumatic brain injury by providing detailed volumetric reports and visual overlays, improving the efficiency and accuracy of brain image analysis.

Arterys MICA is a software platform designed to display, process, store, and transfer medical imaging data, including CT and MR images. It features modules specialized for cardiac and oncology workflows, providing quantitative analysis to aid clinicians in diagnosis. The software runs on standard computers via a web browser and supports enhanced image viewing and lesion evaluation for clinical decision support.

Ziostation2 is an advanced medical image processing software that supports multiple imaging modalities including CT, MRI, Ultrasound, and X-ray. It helps clinicians view and analyze medical images by providing tools for image quantification, manipulation, and communication. This software is designed to enhance the workflow and diagnostic process for radiologists and other trained medical professionals.