FDA Radiology AI Devices

TraumaCad Neo (1.1) is software that helps surgeons plan and evaluate orthopedic procedures by using X-ray images. It overlays measurements and prosthesis templates to assist in surgical planning and postoperative assessment, including automated analysis of hip arthroplasty outcomes using AI. This streamlines workflow and supports clinical decisions prior to and after surgery.

Opulus™ Lymphoma Precision is an AI-powered software tool designed to help physicians analyze whole-body FDG-PET/CT scans of patients with FDG-avid lymphomas. It automatically segments and visualizes lymphoma lesions and calculates the total metabolic tumor volume. This supports physicians by reducing the manual workload and assisting in more efficient interpretation of PET/CT images, although final decisions remain with the radiologist.

AudaxCeph Cephalogram Analysis Software is a specialized software intended for dental professionals to assist in treatment planning by analyzing 2D cephalogram images. It automatically detects landmarks on images, allows measurement and superimposition, and supports orthodontic treatment planning. The software can be used as a desktop application or via the cloud, helping clinicians make informed decisions by digitizing and analyzing dental radiological images efficiently.

Rapid MLS is an AI-powered software that analyzes non-contrast CT scans to measure and visually display brain midline shifts. This helps clinicians assess conditions like intracranial hemorrhage and traumatic brain injury by providing quantitative and annotated images, supporting but not replacing clinical decision-making.

CoLumboX is a software tool that helps healthcare professionals analyze lumbar spine x-ray images by automatically segmenting and measuring spine features. It provides quantitative information and highlights out-of-range measurements to assist in clinical evaluations, supporting more efficient and accurate patient assessments without making diagnoses itself.

Second Opinion® 3D is an AI-powered software that helps dental professionals by automatically identifying and marking important anatomical structures in dental CBCT (Cone Beam Computed Tomography) radiographs. It highlights areas such as dentition, maxilla, mandible, and other key dental anatomical features, supporting clinicians to review images more efficiently and accurately. The software acts as a concurrent and second reader for patients aged 12 years or older, assisting in dental evaluation without replacing full clinical patient assessment.

Clever One is dental imaging software designed to acquire, process, view, and analyze 2D and 3D medical images from dental CT, panoramic, cephalometric, and intraoral imaging devices. It helps clinicians by providing advanced visualization and analytic tools such as bone density analysis, implant planning, and multi-planar reconstructions, facilitating more accurate diagnostics and treatment plans.

Synapse 3D Base Tools (V7.0) is advanced medical imaging software from FUJIFILM designed to assist trained professionals in reading, interpreting, reporting, and planning treatment using images from various modalities such as CT, MRI, X-ray, ultrasound, and nuclear medicine. It provides powerful 3D viewing tools, image fusion, segmentation powered by deep learning, and supports multiple modalities and anatomical regions, which enhances diagnostic workflows and treatment planning for adult patients.

Medical Image Post-processing Software (uOmnispace.CT) is sophisticated software designed to help radiologists and clinicians view, manipulate, evaluate, and analyze CT medical images. It includes multiple specialized processing applications for lungs, heart, brain, liver, bone structure, vascular structures, and more, helping clinicians quantify and characterize anatomical and functional information to support diagnosis and treatment planning.

Second Opinion BLE is a software tool that uses AI to help dental professionals measure bone levels in bitewing and periapical radiographs. It assists clinicians by automatically detecting and displaying bone level measurements to aid in patient assessment, but it is not intended to replace full clinical evaluation.