FDA Radiology AI Devices

Mosaic V1.0.1 is a medical image analysis software that processes CT angiography images to help trained clinicians analyze arterial diseases such as atherosclerosis and aneurysmal disease. It offers 3D vessel visualization, measurements of vessel diameter, stenosis, and tissue volumes, supporting clinical decision-making though it does not provide direct diagnoses.

SMARTDent is a software solution developed by RAY Co., Ltd. that helps dental professionals manage and analyze various types of dental imaging, including CT, panoramic, cephalometric, and intraoral X-rays. It streamlines image management and provides tools that support diagnosis, thereby assisting clinicians in dental care.

LUMYS (V1) is a medical software platform designed to assist clinicians in pre-surgical planning by providing 3D visualization and interactive image segmentation of CT scan data. Using Microsoft HoloLens 2 for a mixed reality view, it enables surgeons and remote collaborators to annotate and interact with medical images in real time during procedures, improving communication and surgical precision, but it is not intended for primary diagnosis.

Horos Mobile is a mobile software application that allows trained healthcare professionals to view and review medical images from CT, MRI, X-ray, ultrasound and other DICOM compliant systems on iOS and iPadOS devices. It facilitates diagnostic image visualization remotely or when full workstations are not available, supporting essential tools for image manipulation and measurement consistent with clinical practice requirements.

brAIn™ Shoulder Positioning is a cloud-based software tool that assists shoulder surgeons in planning total shoulder replacement surgeries. It automatically segments CT images of the shoulder using machine learning, allowing clinicians to visualize shoulder anatomy, position implants interactively in 3D, and receive detailed pre- and post-operative measurements and reports, facilitating more accurate and efficient surgical planning.

CaRi-Plaque is a web-based software application that aids trained medical professionals by automatically analyzing cardiac CT scans to quantify and characterize coronary artery plaques and stenoses. It provides detailed measurements on plaque volumes and vessel stenosis to help clinicians assess coronary artery disease and guide treatment decisions, complementing their clinical judgment.

Brainomix 360 e-CTA is a software system used by trained medical professionals to analyze CT Angiography images of the brain. It processes these images to provide visualizations and quantitative measurements, such as vessel density asymmetry, specifically in the middle cerebral artery region. This helps clinicians assess cerebral blood vessel conditions and supports clinical decision-making for stroke and related conditions. The software uses AI/ML algorithms to improve vessel detection and image quality, and integrates with standard hospital imaging systems for ease of use.

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.

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.

JLK-CTP is an image processing software that helps trained medical professionals analyze brain CT perfusion images. It automatically receives, processes, and visualizes dynamic CT perfusion datasets to calculate blood flow and volume parameters, aiding in the assessment of cerebral blood flow and tissue status in brain imaging.