FDA Radiology AI Devices

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.

Radlink GPS Pro Imaging is an advanced image processing software that assists orthopedic surgeons in hip procedures by measuring the acetabulum’s position relative to bone structures seen in radiological images. The software overlays digital annotations on images and offers measurement tools to help surgeons plan and execute hip, knee, and trauma component positioning more precisely, improving procedural accuracy and outcomes.

SERV MEDICAL CDSS is a medical image processing software designed for trained professionals, enabling viewing, processing, and analysis of imaging data acquired with Digital Subtraction Angiography (DSA). It helps clinicians visualize large vessels and supports clinical decision making by providing comprehensive image viewing and analysis capabilities on standard hardware.

PLANET Onco Dose (3.2) is a specialized software platform designed for medical professionals in molecular imaging and oncology. It helps manage and analyze various anatomical and functional medical images such as CT, MRI, SPECT, PET, and others. The software supports tumor and normal tissue segmentation, image co-registration, therapy response evaluation, and computes radiation doses at a voxel level for radionuclide-based therapies, improving treatment planning and patient care.

aiCockpit AI Viewer is a stand-alone software for clinicians that allows viewing and interacting with medical images and AI annotations within a web browser. It supports various imaging manipulation tools and 3D rendering, helping radiologists review findings effectively by displaying images alongside clinical documents and reports.

JLK-AILink is a software platform designed to help healthcare professionals manage, view, and share medical images from various imaging devices like CT and MRI scanners. It enables efficient processing and annotation of images and supports remote access through mobile devices, enhancing clinical workflows and facilitating timely decision-making for patient care.

QuickRad is a web-based PACS (Picture Archiving and Communication System) designed for radiology centers and hospitals. It manages and displays medical images from various scanners including CT, MRI, ultrasound, and X-ray, and allows users to integrate FDA-cleared AI models to assist radiologists by visualizing AI outputs alongside images. This helps clinicians by improving workflow efficiency and providing advanced image viewing and reporting tools.

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.

AspenView is a software designed to assist radiologists and radiology technicians in annotating, processing, and managing general radiographic X-ray images. It supports standard medical image formats and provides functions such as image stitching, storage, and transmission, helping clinicians handle and review X-ray images efficiently.