FDA Radiology AI Devices

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is a software tool designed to assist trained medical professionals by providing advanced image processing and analysis of MRI and CT scans, specifically for brain perfusion and diffusion imaging. It helps visualize hemodynamic properties and tissue characteristics important for managing conditions like acute stroke by automatically identifying regions of interest and calculating volumetric and perfusion parameters, improving diagnostic and treatment decision workflows for clinicians.

Navbit Rapid Surgical Plan is a software tool designed to assist surgeons in planning primary total hip replacement surgeries. It analyzes X-ray images of a patient's hip and spine to provide recommendations on the placement of hip replacement components, aiming to reduce complications. The software helps surgeons by offering data-driven guidance based on patient-specific anatomy and mobility.

RadUnity (Version 1.0.0) is a software device designed to centralize, manage, standardize, and network CT images using the DICOM protocol. It reformats CT medical images according to user-defined preferences to ensure consistent image formatting, thus supporting qualified radiology professionals in preparing images for interpretation. It is not intended for primary diagnostic review nor for mammographic image interpretation.

Jazz Classic is a dental imaging software that helps dental professionals capture, process, store, and review diagnostic dental images from various devices including intraoral x-ray sensors and scanners. It runs on standard PC hardware and assists clinicians in diagnosis and treatment planning by allowing image enhancement, annotation, and secure image management. This software supports both pediatric and general populations and integrates with dental practice management systems for improved workflow.

CT Collaboration Live is a software application integrated into Philips CT systems that enables real-time remote communication for consultation, training, and support via chat, audio/video calls, screen sharing, and remote control. It facilitates collaboration between CT system operators and remote clinical users but is not intended for remote diagnostic image review.

1CMR Pro is a medical software tool that helps clinicians view and analyze cardiovascular MRI images. It automates analysis of heart structure, function, and blood flow, improving the accuracy and precision of cardiac assessments. This supports better diagnosis and monitoring of heart diseases.

Change Healthcare Stratus Imaging PACS is a cloud-based software system that manages and processes medical images to assist healthcare professionals in diagnosing and interpreting medical images. It offers features like image manipulation, enhancement, and 3D/4D visualization through a zero-footprint browser-based viewer. It supports clinicians by providing tools for reviewing and analyzing images acquired from DICOM-compliant devices, improving workflow with integrated reporting tools and secure access from clinical or remote locations.

JLK-PWI is a software tool used by trained medical professionals to analyze special types of brain MRI scans called diffusion-weighted and perfusion-weighted images. It helps calculate parameters related to tissue water diffusion and blood flow, assisting clinicians in understanding brain tissue conditions. The software integrates with standard hospital imaging systems and allows for viewing and analysis, aiming to support diagnosis and treatment planning.

eRAD PACS is a software-only system that helps medical professionals receive, organize, store, and review medical images and clinical reports from various imaging modalities. It supports hospitals and imaging centers by providing access to diagnostic images and reports via web and custom interfaces, facilitating efficient image management and review for clinicians.

The ROCC Console is a software system that enables remote control, support, and standardization of medical imaging protocols, particularly for MR and CT scanners. It helps technologists and medical personnel operate scanners remotely and manage imaging protocols, improving workflow and access to expertise without requiring physical presence on site.