FDA Radiology AI Devices

VisAble.IO is a software tool that helps doctors plan and confirm liver ablation procedures using CT images. It provides features like segmentation of liver structures, virtual placement of ablation needles, and analysis of ablation zones to support clinicians during treatment. It is designed to improve the accuracy and efficiency of liver ablation therapy planning and evaluation in clinical settings.

Annalise Enterprise CTB Triage-OH is an AI-powered software tool designed to help clinicians prioritize brain CT scans by detecting features suggestive of obstructive hydrocephalus. It integrates with hospital imaging and order management systems to flag and prioritize suspicious cases, enabling faster review and improving clinical workflow without replacing clinical decision-making.

Brainomix 360 Triage ICH is a software tool that uses artificial intelligence to analyze non-contrast brain CT images in acute settings to detect suspected intracranial hemorrhages. It notifies specialists promptly to prioritize patient care and improve workflow efficiency by providing timely alerts via mobile and web applications. It supports clinicians by assisting triage but does not replace diagnostic evaluation.

The Rapid Aneurysm Triage and Notification device by iSchemaView Inc. is an AI-powered software designed to analyze CT angiography images of the head to detect suspected saccular aneurysms. It helps hospital networks and radiologists by prioritizing cases with potential aneurysms for faster review, improving workflow in routine patient care. The software provides notifications and compressed preview images for informational use, supporting radiologists in triage but not intended for diagnosis.

syngo.CT Lung CAD (Version VD30) is a computer-aided detection tool developed by Siemens Healthcare GmbH to help radiologists identify solid and subsolid pulmonary nodules in chest CT scans. The software highlights regions that might be overlooked, improving the accuracy and efficiency of lung nodule detection during radiological review. It can operate as a first or second reader and includes a mode to filter out subsolid and fully calcified nodules for focused analysis.

Spine Auto Views is a software tool that automatically processes CT images of the spine to create anatomically focused reformatted views and labels vertebrae and disc spaces, facilitating quick and consistent review for clinicians. It utilizes deep learning algorithms to generate multiple reformatted image planes without user interaction and exports the results automatically for radiologist reading.

MOZI TPS is a radiation therapy planning software that helps clinicians design and optimize treatment plans for patients with malignant or benign diseases. It uses medical images to assist in contouring anatomical structures automatically with deep learning, performs image registration, and calculates radiation dose distribution using Monte Carlo algorithms. This aids clinicians in accurately planning external beam irradiation with photon beams, improving treatment effectiveness and patient safety.

Axial3D Insight is a cloud-based service that processes medical imaging DICOM data to create detailed 3D digital files or physical 3D printed models. These models assist clinicians in treatment planning and diagnosis across orthopedic trauma, maxillofacial, and cardiovascular applications, improving surgical preparation and outcomes.

DeepCatch is software that analyzes whole-body CT scans to automatically identify and measure various anatomical structures like skin, muscle, fat, internal organs, and the central nervous system. It produces 3D models and quantitative data to help doctors better understand the patient's body composition and anatomy, aiding clinical decisions by providing accurate volume and proportion measurements.

CAC Software by Imbio, Inc. is a machine learning-based post-processing tool that analyzes non-contrast CT images of the chest to assess calcified plaques in the coronary arteries. It quantifies the calcification burden by producing scores and metrics that help clinicians evaluate coronary artery disease risk. The software outputs annotated images and a detailed report, integrating into the standard DICOM workflow to assist physicians without making standalone diagnoses.