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.

qER-Quant is an AI-powered software that processes non-contrast head CT scans to automatically identify and quantify key brain structures such as intracranial hyperdensities, lateral ventricles, and midline shift. It helps clinicians by providing volumetric data and visual overlays to aid in diagnosis and monitoring brain conditions over time.

FDA #
K211222
Product Code
QIH

qER is an AI-powered software designed to analyze non-contrast head CT scans to detect critical conditions like intracranial hemorrhage, mass effect, midline shift, and cranial fractures. It assists clinicians by prioritizing urgent scans for review, helping to speed up diagnosis without altering the original image data.

FDA #
K200921
Product Code
QAS
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