FDA Radiology AI Devices

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.

iQMR is a software package designed to enhance MRI images by reducing noise and improving image quality. It operates on a PC server connected to a network, receiving and transmitting MRI images in DICOM format. This helps medical professionals get clearer images for better diagnosis and analysis.

The UNiD Spine Analyzer is a software tool that helps healthcare professionals view, measure, and analyze medical images related to the spine. It assists in planning orthopedic surgeries by allowing surgeons to perform measurements and plan the placement of surgical implants. This tool enhances surgical planning accuracy and efficiency for spine treatments.

The Illumeo System by Philips Medical Systems Technologies Ltd. is a software platform designed for trained professionals such as radiologists. It manages, processes, and displays medical images and associated patient data from various imaging modalities, supporting visualization, measurements, and tracking changes over time. It enhances workflow through integration with clinical systems and provides advanced viewing tools including 2D/3D views and enterprise web viewers, helping clinicians efficiently interpret imaging studies.

Infinitt PACS 7.0 is a software system designed to store, process, and display medical images across multiple imaging sources. It allows clinicians to view and manipulate images for diagnosis using advanced tools like 3D visualization, hanging protocols, and secure network features, enhancing access to diagnostic information from anywhere via a web interface.

The syngo Application Software by Siemens is a versatile medical imaging software that allows clinicians to view, manipulate, and process medical images in real time. It supports diagnostic image review and various interventional procedures by providing image-guided navigation, fusion of ultrasound with fluoroscopy, and 3D visualization to improve anatomical orientation and procedural accuracy. This software helps clinicians streamline complex procedures and enhances treatment planning and control.

SmartTarget is a software system designed to assist physicians during image-guided prostate procedures by enhancing visualization. It processes 2D transrectal ultrasound images by performing 3D reconstruction and fusing these images with diagnostic scans like MRI or CT. This helps doctors accurately target and navigate instruments during biopsies, ablations, and other treatments, improving procedure precision and patient outcomes.

PixelShine is a software application that improves the quality of CT images by reducing noise, making them clearer to assist radiologists and specialists in diagnosing patients. It connects to existing CT imaging systems, processes the images, and sends enhanced images back for review, facilitating better clinical decisions.

CVI42 is a software tool designed for analyzing CT and MR images of blood vessels. It provides tools for image visualization, processing, vessel centerline and lumen calculations, stenosis evaluation, and lesion characterization. This helps physicians evaluate and track vascular lesions more effectively for improved patient diagnosis and management.

ClearRead +Confirm is a software application that creates enhanced secondary digital chest X-ray images to help healthcare professionals confirm the placement of lines and tubes. This improves visibility on standard chest radiographs, aiding in timely and accurate patient management.