FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

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.

FDA #
K220439
Product Code
QAS

Viz ICH is an AI-powered software tool that analyzes non-contrast CT brain images to detect suspected intracranial hemorrhages. It sends notifications to neurovascular or neurosurgical specialists to facilitate earlier patient review and intervention. The software is integrated with a mobile application for previewing images and managing notifications, though image previewing is non-diagnostic and full diagnosis relies on standard clinical evaluation.

FDA #
K210209
Product Code
QAS

Viz ICH is an AI-based software tool designed to analyze non-contrast CT scans of the brain for signs of intracranial hemorrhage (ICH). When the software detects suspected ICH, it sends notifications to neurovascular or neurosurgical specialists, helping speed up patient care by alerting clinicians early. The system includes a backend server for image processing and a mobile app for reviewing images in a non-diagnostic way for quick assessment and communication.

FDA #
K193658
Product Code
QAS
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