FDA Radiology AI Devices

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.

Viz SDH is an AI-driven software designed to analyze non-contrast CT scans of the head to detect subdural hemorrhages. It provides rapid notifications of suspected cases to neurovascular or neurosurgical specialists through a mobile application, improving workflow efficiency and potentially expediting patient care decisions. The system does not replace diagnostic evaluation but serves as a parallel workflow triage tool to alert specialists early.