FDA Radiology AI Devices

qXR-PTX-PE is an AI-powered software that assists radiologists by automatically analyzing adult chest X-rays to detect signs of pleural effusion and pneumothorax. It helps prioritize cases by providing case-level outputs within the existing PACS/workstation without altering images or providing direct clinical diagnosis, thereby improving workflow efficiency.

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.

UltraSight AI Guidance is a mobile AI-based application that helps non-expert medical professionals acquire high-quality cardiac ultrasound images by providing real-time guidance on how to position and manipulate the ultrasound probe for standard transthoracic echocardiography views. It enhances image acquisition quality and enables better diagnosis even by novice users.

Annalise Enterprise CTB Triage Trauma is an AI-powered software that assists clinicians by automatically analyzing brain CT scans to identify signs of acute hemorrhages. It helps prioritize studies in the workflow to ensure patients with urgent findings are reviewed faster, improving triage and clinical efficiency. The system integrates with existing imaging management systems and does not provide standalone diagnostic decisions but supports clinicians in managing their workload.

Annalise Enterprise CXR Triage Trauma is an AI-based software tool designed to assist clinicians by analyzing adult chest X-ray images to detect features suggestive of vertebral compression fractures. It integrates with hospital image and order management systems to prioritize cases with potential fractures, facilitating timely review in clinical workflows such as Bone Health and Fracture Liaison Service programs. The device supports clinicians in identifying urgent cases but does not replace clinical decision-making.

Annalise Enterprise CXR Triage Trauma is an artificial intelligence-based software that assists clinicians by automatically analyzing adult chest X-rays to identify signs of pleural effusion and pneumoperitoneum. It integrates with hospital imaging systems to prioritize urgent cases in the clinical workflow, helping healthcare providers quickly identify critical findings and streamline patient care.

Viz AAA is an AI-powered software device designed to analyze CT angiogram images of the abdomen to detect suspected abdominal aortic aneurysms. It helps specialists prioritize patient studies by flagging those with potential aneurysms, improving workflow efficiency in clinical settings. The software provides non-diagnostic preview images and emphasizes that diagnostic decisions remain with treating specialists.

Rapid NCCT Stroke is software that uses artificial intelligence to analyze non-contrast head CT scans and quickly notify clinicians about suspected areas of brain hemorrhage or large vessel blockage. This helps prioritize urgent cases and speeds up patient care, but it is intended to assist—not replace—clinical judgment and diagnosis.

Oncospace is a software tool that assists radiation oncologists and medical dosimetrists in planning radiotherapy treatments for patients with cancer in the prostate, head, and neck regions. It uses locked machine learning algorithms to predict achievable dose objectives for organs at risk based on the patient's anatomy and automates aspects of treatment plan optimization. This helps clinicians customize treatment protocols, optimize radiation dose delivery while sparing healthy tissue, and review treatment plans efficiently, ultimately supporting better patient care in radiation oncology.