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.

HealthICH is an AI software tool designed to analyze non-contrast head CT scans and identify suspected cases of intracranial hemorrhage. It notifies the clinician via the PACS/workstation to prioritize these urgent cases, helping reduce the time to diagnosis and potentially improving patient care. It operates alongside standard workflows and assists clinicians by flagging critical findings for faster review.

FDA #
K190424
Product Code
QAS
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