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.

syngo.CT Brain Hemorrhage by Siemens Medical Solutions is an AI-powered software that helps radiologists prioritize CT scans suspected of having intracranial or subarachnoid hemorrhages. It analyzes head CT images to flag cases for earlier review, improving workflow efficiency. This software is not for diagnosis but supports clinicians by highlighting urgent cases based on AI detection of hemorrhages.

FDA #
K232431
Product Code
QAS

syngo.CT Brain Hemorrhage is an AI-driven software that assists radiologists by analyzing non-contrast head CT scans to prioritize cases suspicious for acute intracranial hemorrhage. It flags findings to improve workflow efficiency by enabling faster review of urgent cases but is not intended for standalone diagnosis.

FDA #
K203260
Product Code
QAS
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